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CompletedNCT02064985Updated May 11, 2016Results posted

Ticagrelor China Pharmacokinetic/Pharmacodynamic Study

A Phase 4 interventional study of Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) in Stable Coronary Heart Disease (CHD), sponsored by AstraZeneca. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-11.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese patients with stable coronary heart disease

Read the detailed description

Up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.Ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. Following an 8 hour fast on single dose on Day 1 and Day 7; on multiple doses from Day 3 to Day 6. Prior to the first dose of study drug there will be a screening period of maximum of 19 days. Patients will report to the clinical pharmacology unit (CPU) on Day -2 and will remain confined there until completion of study procedures on Day 7, the patients will be discharged on Day 8. In addition, patients will return to the CPU for a follow up visit 2 to 5 days after the last dose. Each patients participation, including the screening period, will take approximately 33 days.

02

Conditions studied

  • Stable Coronary Heart Disease (CHD)
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of signed and dated written informed consent prior to any study specific procedures.
  2. Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures.

  3. Documented stable coronary heart disease (CHD) fulfilling all of the following, and taking 75-100 mg ASA daily treatment:

    Diagnosed stable angina pectoris per the guidance of Chinese Society of Cardiology published in 2007, patients with angina severity classified as I and II of Canadian Cardiovascular Society grading of angina pectoris.

  4. Female patients without pregnant potential

Exclusion criteria

Exclusion Criteria:

  1. Any indication for oral anticoagulant or dual antiplatelet treatment and chronic ASA with doses greater than 100 mg/day.
  2. Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days preceding the first dose of study medication and during study treatment.
  3. Increased bleeding risk.
  4. Contraindication or other reason that ASA or ticagrelor should not be administered
  5. Patients that are scheduled for revascularization (eg, PCI, CABG) during the study period
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Ticagrelor 45mg

    A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.

    Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)

  • Experimental
    Ticagrelor 60mg

    A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.

    Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)

  • Experimental
    Ticagrelor 90mg

    A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.

    Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)

Interventions

  • DrugInhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)

    To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).

    Also known as: "Brilinta"(Ticagrelor)

06

What researchers measure

Primary outcomes

  1. IPA on Day 1

    The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).

    Time frame: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1

  2. IPA on Day 7

    The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).

    Time frame: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7

Secondary outcomes

  1. Percent Change From Baseline in PRU on Day 1

    Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.

    Time frame: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1

  2. Pharmacokinetics Parameters of Ticagrelor on Day 7(1)

    Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  3. Safety---Vital Signs Over Time---Blood Pressure

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (seated blood pressure \[BP\])

    Time frame: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose

  4. Percent Change From Baseline in PRU on Day 7

    Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.

    Time frame: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7

  5. TIPA(Max)---Day 1

    The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.

    Time frame: Day 1

  6. TIPA(Max)---Day 7

    The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.

    Time frame: Day 7

  7. AUEC(Final Extent) on Day 1

    The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.

    Time frame: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1

  8. AUEC(Final Extent) on Day 7

    The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.

    Time frame: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  9. Pharmacokinetics Parameters of Ticagrelor on Day 1(3)

    The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1

  10. Pharmacokinetics Parameters of Ticagrelor on Day 1(2)

    The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1

  11. Pharmacokinetics Parameters of Ticagrelor on Day 7(2)

    The pharmacokinetics parameters of ticagrelor on Day 7---tmax

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  12. Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)

    Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1

  13. Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)

    Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1

  14. Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)

    Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  15. Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)

    Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  16. Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax

    To determine Cmax ratio for the metabolite to that of the parent compound on Day 1

    Time frame: Day 1

  17. Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax

    To determine Cmax ratio of metabolite to that of the parent compound on Day 7

    Time frame: Day 7

  18. Safety---Physical Examination, Summary of Abnormalities

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Physical examination

    Time frame: 2 to 5 days after last dose

  19. Safety---Hematology Laboratory Variables Over Time---hematocrit

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---hematocrit

    Time frame: 2 to 5 days after last dose

  20. Safety---All Allowed Concomitant Medications During Study Treatment

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Concomitant medications

    Time frame: All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.

  21. Safety---Causally Related Adverse Events by System Organ Class and Preferred Term

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Assessment of adverse events

    Time frame: Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).

  22. Pharmacokinetics Parameters of Ticagrelor on Day 1(1)

    The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1

  23. Pharmacokinetics Parameters of Ticagrelor on Day 7(3)

    Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  24. Pharmacokinetics Parameters of Ticagrelor on Day 7(4)

    Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  25. Safety---Vital Signs Over Time---Height

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Height)

    Time frame: Baseline

  26. Safety---Vital Signs Over Time---Weight

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Weight)

    Time frame: Baseline

  27. Safety---Vital Signs Over Time---Pulse Rate

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Pulse Rate)

    Time frame: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose

  28. Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)

    Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1

  29. Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)

    Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  30. Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)

    Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))

    Time frame: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7

  31. Safety---Hematology Laboratory Variables Over Time---Erythrocytes

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Erythrocytes

    Time frame: 2 to 5 days after last dose

  32. Safety---Hematology Laboratory Variables Over Time---Hemoglobin

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Hemoglobin

    Time frame: 2 to 5 days after last dose

  33. Safety---Hematology Laboratory Variables Over Time---Leukocytes

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Leukocytes

    Time frame: 2 to 5 days after last dose

  34. Safety---Hematology Laboratory Variables Over Time---Platelets

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Platelets

    Time frame: 2 to 5 days after last dose

  35. Safety---Clinical Chemistry Variables Over Time---Glucose

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Glucose

    Time frame: 2 to 5 days after last dose

  36. Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alanine Aminotransferase

    Time frame: 2 to 5 days after last dose

  37. Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Aspartate Aminotransferase

    Time frame: 2 to 5 days after last dose

  38. Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alkaline Phosphatase

    Time frame: 2 to 5 days after last dose

  39. Safety---Clinical Chemistry Variables Over Time---Creatinine

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Creatinine

    Time frame: 2 to 5 days after last dose

  40. Safety---Clinical Chemistry Variables Over Time---Total Bilirubin

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Total Bilirubin

    Time frame: 2 to 5 days after last dose

  41. Safety---Clinical Chemistry Variables Over Time---Sodium

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Sodium

    Time frame: 2 to 5 days after last dose

  42. Safety---Clinical Chemistry Variables Over Time---Potassium

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Potassium

    Time frame: 2 to 5 days after last dose

  43. Safety---Clinical Chemistry Variables Over Time---Chloride

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Chloride

    Time frame: 2 to 5 days after last dose

  44. Safety---Clinical Chemistry Variables Over Time---Phosphate

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Phosphate

    Time frame: 2 to 5 days after last dose

  45. Safety---Clinical Chemistry Variables Over Time---Albumin

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Albumin

    Time frame: 2 to 5 days after last dose

  46. Safety---Clinical Chemistry Variables Over Time---Protein

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Protein

    Time frame: 2 to 5 days after last dose

  47. Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Blood Urea Nitrogen

    Time frame: 2 to 5 days after last dose

  48. Safety---Clinical Chemistry Variables Over Time---Bicarbonate

    The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Bicarbonate

    Time frame: 2 to 5 days after last dose

  49. Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)

    To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1

    Time frame: Day 1

  50. Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)

    To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.

    Time frame: Day 7

07

Results

Posted May 11, 2016

Participant flow

The first patient was recruited on February 27th 2014 and the last patient's informed consent was obtained on Oct 24th 2014.

Participant flow — Overall Study
MilestoneTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Started121212
Completed121212
Not completed000

Outcome measures

PrimaryIPA on Day 1

The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).

Time frame:
Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Reported as:
Mean · % IPA
IPA on Day 1
% IPATicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
0.5 hour after dose intake27.09 ± 25.95625.87 ± 27.03633.34 ± 31.238
1 hour after dose intake57.20 ± 26.56350.97 ± 32.74761.64 ± 31.244
2 hours after dose intake82.24 ± 21.16084.10 ± 17.64586.11 ± 22.213
3 hours after dose intake88.44 ± 11.78690.18 ± 9.23296.24 ± 6.396
6 hours after dose intake85.02 ± 8.96594.32 ± 6.24394.02 ± 6.190
12 hours after dose intake71.25 ± 16.51885.70 ± 15.23790.70 ± 8.117
24 hours after dose intake44.11 ± 34.16549.38 ± 25.15366.48 ± 21.200
36 hours after dose intake40.09 ± 28.21146.23 ± 17.35255.64 ± 29.446
48 hours after dose intake23.56 ± 22.95627.25 ± 17.99343.04 ± 25.178
SecondaryPercent Change From Baseline in PRU on Day 1

Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Time frame:
Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Reported as:
Mean · % change from baseline
Percent Change From Baseline in PRU on Day 1
% change from baselineTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
0.5 hour after dose intake-19.20 ± 13.712-13.76 ± 22.786-19.59 ± 23.880
1 hour after dose intake-60.00 ± 27.295-35.25 ± 28.795-67.70 ± 30.613
2 hours after dose intake-72.60 ± 16.492-61.23 ± 23.304-78.85 ± 18.775
3 hours after dose intake-71.58 ± 22.220-75.42 ± 15.315-87.97 ± 11.134
6 hours after dose intake-60.27 ± 25.208-67.98 ± 16.709-81.08 ± 11.024
12 hours after dose intake-41.93 ± 23.584-47.15 ± 20.310-73.47 ± 13.705
24 hours after dose intake-35.94 ± 20.706-28.34 ± 19.865-54.61 ± 19.553
36 hours after dose intake-9.57 ± 17.655-1.91 ± 18.120-22.59 ± 24.694
48hours after dose intake-15.19 ± 23.331-0.57 ± 13.070-16.38 ± 18.164
SecondaryPharmacokinetics Parameters of Ticagrelor on Day 7(1)

Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Geometric mean · ng/mL
Pharmacokinetics Parameters of Ticagrelor on Day 7(1)
ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Ticagrelor on Day 7(1)616.0 ± 37.09689.4 ± 33.641273 ± 43.00
SecondarySafety---Vital Signs Over Time---Blood Pressure

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (seated blood pressure \[BP\])

Time frame:
Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Reported as:
Mean · mmHg
Safety---Vital Signs Over Time---Blood Pressure
mmHgTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Diastolic Blood Pressure- Baseline84.6 ± 7.677.1 ± 9.774.8 ± 15.5
Diastolic Blood Pressure- Day 185.3 ± 9.078.2 ± 9.674.6 ± 11.3
Diastolic Blood Pressure-Day 282.3 ± 9.374.8 ± 7.574.2 ± 11.3
Diastolic Blood Pressure-Day 379.2 ± 11.075.2 ± 7.574.3 ± 11.5
Diastolic Blood Pressure-Day 480.7 ± 11.478.2 ± 8.773.3 ± 11.2
Diastolic Blood Pressure-Day 580.8 ± 10.375.2 ± 5.674.7 ± 9.5
Diastolic Blood Pressure-Day 679.8 ± 8.777.4 ± 4.873.9 ± 11.5
Diastolic Blood Pressure-Day 780.8 ± 7.775.6 ± 6.774.0 ± 11.5
Diastolic Blood Pressure-2-5 days after last Dose80.3 ± 6.874.7 ± 6.771.3 ± 9.2
Systolic Blood Pressure (mmHg)-Baseline134.6 ± 14.6129.2 ± 11.6132.1 ± 14.5
Systolic Blood Pressure-Day 1132.2 ± 12.0135.7 ± 19.2127.4 ± 11.9
Systolic Blood Pressure-Day 2130.3 ± 15.0131.4 ± 20.0123.1 ± 14.2
Systolic Blood Pressure-Day 3128.3 ± 11.0130.1 ± 18.8123.8 ± 9.5
Systolic Blood Pressure-Day 4131.3 ± 12.8132.8 ± 15.3126.1 ± 12.0
Systolic Blood Pressure-Day 5129.4 ± 11.0131.3 ± 18.6125.1 ± 11.0
Systolic Blood Pressure-Day 6126.8 ± 14.0133.5 ± 19.5119.1 ± 9.2
Systolic Blood Pressure-Day 7128.9 ± 11.8129.4 ± 22.7122.1 ± 11.3
Systolic Blood Pressure-2-5 days after last Dose126.0 ± 16.0132.3 ± 17.3124.7 ± 13.9
PrimaryIPA on Day 7

The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).

Time frame:
Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
Reported as:
Mean · % IPA
IPA on Day 7
% IPATicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
0 hour after dose intake79.69 ± 20.54789.26 ± 7.85795.10 ± 6.910
0.5 hour after dose intake84.70 ± 15.99889.96 ± 7.98596.90 ± 3.602
1 hour after dose intake88.82 ± 15.63993.28 ± 7.58996.47 ± 4.184
2 hours after dose intake88.30 ± 17.32594.62 ± 3.78798.29 ± 3.526
3 hours after dose intake91.00 ± 13.21297.01 ± 2.25898.86 ± 2.664
6 hours after dose intake91.13 ± 14.34492.94 ± 17.84798.87 ± 2.598
12 hours after dose intake86.55 ± 16.91892.01 ± 7.31696.81 ± 4.219
SecondaryPercent Change From Baseline in PRU on Day 7

Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.

Time frame:
Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
Reported as:
Mean · % change from baseline
Percent Change From Baseline in PRU on Day 7
% change from baselineTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
0.5 hour after dose intake-77.90 ± 17.632-80.07 ± 14.691-89.33 ± 8.923
1 hour after dose intake-79.70 ± 17.742-78.40 ± 18.103-94.10 ± 6.746
2 hours after dose intake-82.23 ± 17.304-85.00 ± 12.020-88.81 ± 13.595
3 hours after dose intake-79.98 ± 18.434-86.96 ± 12.868-92.13 ± 9.288
6 hours after dose intake-76.71 ± 20.067-75.07 ± 14.806-91.48 ± 7.928
12 hours after dose intake-63.63 ± 23.767-69.03 ± 19.867-88.60 ± 8.816
SecondaryTIPA(Max)---Day 1

The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.

Time frame:
Day 1
Reported as:
Median · hour
TIPA(Max)---Day 1
hourTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
TIPA(Max)---Day 13.0 ± 17.6324.5 ± 14.6912.5 ± 8.923
SecondaryTIPA(Max)---Day 7

The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.

Time frame:
Day 7
Reported as:
Median · hour
TIPA(Max)---Day 7
hourTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
TIPA(Max)---Day 71.5 ± 17.6326.0 ± 14.6911.3 ± 8.923
SecondaryAUEC(Final Extent) on Day 1

The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.

Time frame:
IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Reported as:
Mean · %*h
AUEC(Final Extent) on Day 1
%*hTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
AUEC(Final Extent) on Day 12474.4 ± 949.32819.4 ± 707.173301.0 ± 788.72
SecondaryAUEC(Final Extent) on Day 7

The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.

Time frame:
IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Mean · %*h
AUEC(Final Extent) on Day 7
%*hTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
AUEC(Final Extent) on Day 71069.9 ± 176.891120.1 ± 108.441176.9 ± 33.03
SecondaryPharmacokinetics Parameters of Ticagrelor on Day 1(3)

The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Reported as:
Median · hour
Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
hourTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
tmax2.00 ± 38.023.00 ± 34.142.00 ± 37.39
t½10.07 ± 51.429.008 ± 32.469.802 ± 53.84
SecondaryPharmacokinetics Parameters of Ticagrelor on Day 1(2)

The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Reported as:
Geometric mean · h*ng/mL
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
h*ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
AUC(0-inf)3220 ± 51.423633 ± 32.466234 ± 53.84
AUC(0-t)3102 ± 49.793533 ± 31.686017 ± 51.71
AUC(0-12h)2114 ± 41.972313 ± 30.103983 ± 41.93
SecondaryPharmacokinetics Parameters of Ticagrelor on Day 7(2)

The pharmacokinetics parameters of ticagrelor on Day 7---tmax

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Median · hour
Pharmacokinetics Parameters of Ticagrelor on Day 7(2)
hourTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Ticagrelor on Day 7(2)2.00 ± 37.092.00 ± 33.642.00 ± 43.00
SecondaryPharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)

Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Reported as:
Geometric mean · ng/mL
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)
ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)88.28 ± 24.5877.11 ± 53.92138.6 ± 38.37
SecondaryPharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)

Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Reported as:
Median · hour
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)
hourTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
tmax2.00 ± 38.023.00 ± 34.143.00 ± 37.39
t½13.16 ± 51.4211.64 ± 32.4611.29 ± 53.84
SecondaryPharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)

Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Geometric mean · ng/mL
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)
ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)143.7 ± 26.32180.1 ± 49.83300.6 ± 31.74
SecondaryPharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)

Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Median · hour
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)
hourTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)2.00 ± 38.022.00 ± 34.142.54 ± 37.39
SecondaryPharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax

To determine Cmax ratio for the metabolite to that of the parent compound on Day 1

Time frame:
Day 1
Reported as:
Mean · ratio
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax
ratioTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax0.2277 ± 0.089840.2146 ± 0.063330.2005 ± 0.08334
SecondaryPharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax

To determine Cmax ratio of metabolite to that of the parent compound on Day 7

Time frame:
Day 7
Reported as:
Mean · ratio
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax
ratioTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax0.2657 ± 0.078200.3082 ± 0.12230.2646 ± 0.06758
SecondarySafety---Physical Examination, Summary of Abnormalities

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Physical examination

Time frame:
2 to 5 days after last dose
Reported as:
Number · Participants
Safety---Physical Examination, Summary of Abnormalities
ParticipantsTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Number of patients with abnormality5 ± 7.63 ± 9.72 ± 15.6
Abdomen1 ± 9.00 ± 9.60 ± 11.3
Cardiovascular0 ± 16.00 ± 17.30 ± 13.9
General appearance000
Head and neck000
Lymph nodes000
Musculoskeletal / Extremities000
Neurological000
Respiratory000
Skin432
Thyroid000
SecondarySafety---Hematology Laboratory Variables Over Time---hematocrit

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---hematocrit

Time frame:
2 to 5 days after last dose
Reported as:
Mean · ratio
Safety---Hematology Laboratory Variables Over Time---hematocrit
ratioTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Hematology Laboratory Variables Over Time---hematocrit0.4083 ± 0.03650.4020 ± 0.04650.4153 ± 0.0369
SecondarySafety---All Allowed Concomitant Medications During Study Treatment

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Concomitant medications

Time frame:
All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.
Reported as:
Number · Participants
Safety---All Allowed Concomitant Medications During Study Treatment
ParticipantsTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Number of patients with allowed concomitant med12 ± 3.6512 ± 1.8612 ± 1.19
HMG CoA reductase inhibitors11 ± 0.29712 ± 0.18612 ± 0.216
ATORVASTATIN5 ± 0.2008 ± 0.1345 ± 0.109
SIMVASTATIN3 ± 0.3014 ± 0.1113 ± 0.179
ROSUVASTATIN3 ± 12.250 ± 17.894 ± 13.48
Beta blocking agents, selective9 ± 4.3610 ± 5.916 ± 9.67
METOPROLOL6 ± 1.56 ± 1.45 ± 2.6
BISOPROLOL3 ± 0.365 ± 0.331 ± 0.25
ACE inhibitors, plain5 ± 1.62 ± 2.06 ± 2.5
PERINDOPRIL203
FOSINOPRIL112
ENALAPRIL011
BENAZEPRIL100
IMIDAPRIL100
Dihydropyridine derivatives432
AMLODIPINE332
NIFEDIPINE100
Other cardiac preparations422
TRIMETAZIDINE421
TRIMETAZIDINE HYDROCHLORIDE001
Biguanides322
METFORMIN222
METFORMIN HYDROCHLORIDE100
Organic nitrates123
ISOSORBIDE MONONITRATE123
Angiotensin II antagonists, plain311
IRBESARTAN210
LOSARTAN100
TELMISARTAN001
Alpha glucosidase inhibitors310
ACARBOSE310
Insulins and analogues for injection, fast-acting130
INSULIN120
INSULIN HUMAN010
Enzymes012
KALLIDINOGENASE012
Folic acid and derivatives210
FOLIC ACID210
Alpha and beta blocking agents101
CARVEDILOL101
Other therapeutic products020
CHINESE TRADITIONAL MEDICINE NOS010
HERBAL NOS010
Preparations inhibiting uric acid production200
ALLOPURINOL200
Sulfonamides, urea derivatives101
GLIMEPIRIDE001
GLIQUIDONE100
ANTIHYPERTENSIVES001
ANTIHYPERTENSIVES001
Aldose reductase inhibitors010
EPALRESTAT010
Angiotensin II antagonists and diuretics001
HYDROCHLOROTHIAZIDE+ LOSARTAN001
Antidepressants in combination with psycholeptics010
FLUPENTIXOL+MELITRACEN010
Benzodiazepine derivatives010
ESTAZOLAM010
Benzothiazepine derivatives100
DILTIAZEM100
Comb/complexes aluminium, calcium, magnesium comps100
HYDROTALCITE100
Fibrates001
FENOFIBRATE001
Insulins and analogues for inj,intermediate-acting100
HUMULIN 70/30100
Insulins/analogues for inj,int/long-act+fast-actin100
INSULIN ASPART100
Nicotinic acid and derivatives010
ACIPIMOX010
Other antifungals for topical use100
TERBINAFINE HYDROCHLORIDE100
Other drugs for peptic ulcer and GORD001
GEFARNATE001
Other vasodilators used in cardiac diseases010
NICORANDIL010
Thiazolidinediones010
ROSIGLITAZONE010
SecondarySafety---Causally Related Adverse Events by System Organ Class and Preferred Term

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Assessment of adverse events

Time frame:
Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).
Reported as:
Number · Participants
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
ParticipantsTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Patients with any causally related AE1 ± 3.652 ± 1.862 ± 1.19
Respiratory, thoracic and mediastinal disorders0 ± 0.2972 ± 0.1862 ± 0.216
Dyspnoea0 ± 0.2002 ± 0.1341 ± 0.109
Haemoptysis0 ± 0.3010 ± 0.1111 ± 0.179
Gastrointestinal disorders1 ± 12.250 ± 17.890 ± 13.48
Diarrhoea1 ± 4.360 ± 5.910 ± 9.67
Investigations1 ± 1.50 ± 1.40 ± 2.6
Occult blood positive1 ± 0.360 ± 0.330 ± 0.25
SecondaryPharmacokinetics Parameters of Ticagrelor on Day 1(1)

The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Reported as:
Geometric mean · ng/mL
Pharmacokinetics Parameters of Ticagrelor on Day 1(1)
ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Ticagrelor on Day 1(1)464.0 ± 38.02413.9 ± 34.14822.1 ± 37.39
SecondaryPharmacokinetics Parameters of Ticagrelor on Day 7(3)

Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Geometric mean · h*ng/mL
Pharmacokinetics Parameters of Ticagrelor on Day 7(3)
h*ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Ticagrelor on Day 7(3)3882 ± 41.674351 ± 36.748206 ± 50.92
SecondaryPharmacokinetics Parameters of Ticagrelor on Day 7(4)

Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Geometric mean · ratio
Pharmacokinetics Parameters of Ticagrelor on Day 7(4)
ratioTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Ticagrelor on Day 7(4)1.837 ± 23.571.882 ± 20.722.060 ± 22.84
SecondarySafety---Vital Signs Over Time---Height

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Height)

Time frame:
Baseline
Reported as:
Mean · cm
Safety---Vital Signs Over Time---Height
cmTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Vital Signs Over Time---Height166.9 ± 7.6168.8 ± 8.0166.5 ± 7.7
SecondarySafety---Vital Signs Over Time---Weight

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Weight)

Time frame:
Baseline
Reported as:
Mean · kg
Safety---Vital Signs Over Time---Weight
kgTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Vital Signs Over Time---Weight78.7 ± 10.273.8 ± 8.573.4 ± 9.8
SecondarySafety---Vital Signs Over Time---Pulse Rate

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Pulse Rate)

Time frame:
Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Reported as:
Mean · BEATS/MIN
Safety---Vital Signs Over Time---Pulse Rate
BEATS/MINTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pulse Rate (BEATS/MIN)- Baseline63.3 ± 8.660.5 ± 6.859.1 ± 5.5
Pulse Rate (BEATS/MIN)- Day 164.2 ± 8.460.6 ± 6.561.3 ± 5.2
Pulse Rate (BEATS/MIN)- Day 264.6 ± 10.659.8 ± 7.363.3 ± 7.2
Pulse Rate (BEATS/MIN)- Day 367.3 ± 9.860.4 ± 7.161.3 ± 4.4
Pulse Rate (BEATS/MIN)- Day 465.3 ± 9.261.7 ± 5.563.7 ± 6.5
Pulse Rate (BEATS/MIN)- Day 566.7 ± 8.562.7 ± 7.164.2 ± 5.9
Pulse Rate (BEATS/MIN)- Day 666.8 ± 8.559.9 ± 7.264.1 ± 4.4
Pulse Rate (BEATS/MIN)- Day 765.4 ± 6.262.7 ± 7.862.9 ± 5.7
Pulse Rate(BEATS/MIN)- 2 to 5 days after last dose64.6 ± 10.961.8 ± 5.563.0 ± 6.8
SecondaryPharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)

Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Reported as:
Geometric mean · h*ng/mL
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
h*ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
AUC(0-inf)921.5 ± 28.661108 ± 34.831644 ± 30.83
AUC(0-t)839.6 ± 25.23906.0 ± 56.841534 ± 28.88
AUC(0-12h)464.0 ± 19.11504.1 ± 55.41835.9 ± 29.59
SecondaryPharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)

Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Geometric mean · h*ng/mL
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)
h*ng/mLTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)1069 ± 24.891314 ± 41.022254 ± 37.02
SecondaryPharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)

Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))

Time frame:
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Reported as:
Geometric mean · ratio
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)
ratioTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)2.304 ± 24.702.606 ± 28.342.697 ± 27.42
SecondarySafety---Hematology Laboratory Variables Over Time---Erythrocytes

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Erythrocytes

Time frame:
2 to 5 days after last dose
Reported as:
Mean · 10^12/L
Safety---Hematology Laboratory Variables Over Time---Erythrocytes
10^12/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Hematology Laboratory Variables Over Time---Erythrocytes4.417 ± 0.3194.409 ± 0.4004.487 ± 0.427
SecondarySafety---Hematology Laboratory Variables Over Time---Hemoglobin

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Hemoglobin

Time frame:
2 to 5 days after last dose
Reported as:
Mean · g/L
Safety---Hematology Laboratory Variables Over Time---Hemoglobin
g/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Hematology Laboratory Variables Over Time---Hemoglobin137.3 ± 11.6135.4 ± 15.2138.6 ± 12.9
SecondarySafety---Hematology Laboratory Variables Over Time---Leukocytes

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Leukocytes

Time frame:
2 to 5 days after last dose
Reported as:
Mean · 10^9/L
Safety---Hematology Laboratory Variables Over Time---Leukocytes
10^9/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Hematology Laboratory Variables Over Time---Leukocytes6.64 ± 1.236.30 ± 1.126.74 ± 1.29
SecondarySafety---Hematology Laboratory Variables Over Time---Platelets

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Platelets

Time frame:
2 to 5 days after last dose
Reported as:
Mean · 10^9/L
Safety---Hematology Laboratory Variables Over Time---Platelets
10^9/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Hematology Laboratory Variables Over Time---Platelets205.3 ± 34.5186.7 ± 38.5227.3 ± 42.4
SecondarySafety---Clinical Chemistry Variables Over Time---Glucose

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Glucose

Time frame:
2 to 5 days after last dose
Reported as:
Mean · mmol/L
Safety---Clinical Chemistry Variables Over Time---Glucose
mmol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Glucose7.48 ± 3.657.26 ± 1.865.78 ± 1.19
SecondarySafety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alanine Aminotransferase

Time frame:
2 to 5 days after last dose
Reported as:
Mean · ukat/L
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
ukat/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase0.524 ± 0.2970.429 ± 0.1860.465 ± 0.216
SecondarySafety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Aspartate Aminotransferase

Time frame:
2 to 5 days after last dose
Reported as:
Mean · ukat/L
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
ukat/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase0.497 ± 0.2000.410 ± 0.1340.433 ± 0.109
SecondarySafety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alkaline Phosphatase

Time frame:
2 to 5 days after last dose
Reported as:
Mean · ukat/L
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
ukat/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase1.172 ± 0.3011.027 ± 0.1111.028 ± 0.179
SecondarySafety---Clinical Chemistry Variables Over Time---Creatinine

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Creatinine

Time frame:
2 to 5 days after last dose
Reported as:
Mean · umol/L
Safety---Clinical Chemistry Variables Over Time---Creatinine
umol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Creatinine81.92 ± 12.2587.50 ± 17.8983.50 ± 13.48
SecondarySafety---Clinical Chemistry Variables Over Time---Total Bilirubin

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Total Bilirubin

Time frame:
2 to 5 days after last dose
Reported as:
Mean · umol/L
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
umol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin13.98 ± 4.3614.58 ± 5.9114.81 ± 9.67
SecondarySafety---Clinical Chemistry Variables Over Time---Sodium

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Sodium

Time frame:
2 to 5 days after last dose
Reported as:
Mean · mmol/L
Safety---Clinical Chemistry Variables Over Time---Sodium
mmol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Sodium140.7 ± 1.5140.8 ± 1.4141.3 ± 2.6
SecondarySafety---Clinical Chemistry Variables Over Time---Potassium

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Potassium

Time frame:
2 to 5 days after last dose
Reported as:
Mean · mmol/L
Safety---Clinical Chemistry Variables Over Time---Potassium
mmol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Potassium4.41 ± 0.364.47 ± 0.334.26 ± 0.25
SecondarySafety---Clinical Chemistry Variables Over Time---Chloride

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Chloride

Time frame:
2 to 5 days after last dose
Reported as:
Mean · mmol/L
Safety---Clinical Chemistry Variables Over Time---Chloride
mmol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Chloride103.2 ± 1.6103.9 ± 2.0104.4 ± 2.5
SecondarySafety---Clinical Chemistry Variables Over Time---Phosphate

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Phosphate

Time frame:
2 to 5 days after last dose
Reported as:
Mean · mmol/L
Safety---Clinical Chemistry Variables Over Time---Phosphate
mmol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Phosphate1.188 ± 0.1831.154 ± 0.1581.145 ± 0.101
SecondarySafety---Clinical Chemistry Variables Over Time---Albumin

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Albumin

Time frame:
2 to 5 days after last dose
Reported as:
Mean · g/L
Safety---Clinical Chemistry Variables Over Time---Albumin
g/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Albumin44.77 ± 1.5144.68 ± 2.5446.07 ± 2.25
SecondarySafety---Clinical Chemistry Variables Over Time---Protein

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Protein

Time frame:
2 to 5 days after last dose
Reported as:
Mean · g/L
Safety---Clinical Chemistry Variables Over Time---Protein
g/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Protein70.2 ± 3.669.8 ± 3.070.2 ± 4.5
SecondarySafety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Blood Urea Nitrogen

Time frame:
2 to 5 days after last dose
Reported as:
Mean · mmol/L
Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen
mmol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen5.875 ± 1.5006.392 ± 1.6486.108 ± 1.366
SecondarySafety---Clinical Chemistry Variables Over Time---Bicarbonate

The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Bicarbonate

Time frame:
2 to 5 days after last dose
Reported as:
Mean · mmol/L
Safety---Clinical Chemistry Variables Over Time---Bicarbonate
mmol/LTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Safety---Clinical Chemistry Variables Over Time---Bicarbonate28.92 ± 2.7728.55 ± 1.9528.15 ± 3.20
SecondaryPharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)

To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1

Time frame:
Day 1
Reported as:
Mean · ratio
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)
ratioTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)0.3310 ± 0.098380.3403 ± 0.073810.3106 ± 0.1283
SecondaryPharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)

To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.

Time frame:
Day 7
Reported as:
Mean · ratio
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)
ratioTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)0.3132 ± 0.088990.3549 ± 0.13510.3153 ± 0.1120

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ticagrelor 45mg—0/12 (0%)4/12 (33.3%)
Ticagrelor 60mg—0/12 (0%)4/12 (33.3%)
Ticagrelor 90mg—0/12 (0%)5/12 (41.7%)
Most frequent other events
Showing 10 of 19
Most frequent other events
EventTicagrelor 45mgTicagrelor 60mgTicagrelor 90mg
DyspnoeaRespiratory, thoracic and mediastinal disorders0/122/121/12
DiarrhoeaGastrointestinal disorders1/121/122/12
Tinea pedisInfections and infestations1/120/120/12
HypoglycaemiaMetabolism and nutrition disorders1/121/120/12
Vision blurredEye disorders0/121/120/12
Cardiac discomfortCardiac disorders0/121/121/12
Ventricular extrasystolesCardiac disorders0/120/121/12
PalpitationsCardiac disorders0/121/120/12
HaemoptysisRespiratory, thoracic and mediastinal disorders0/120/121/12
EpistaxisRespiratory, thoracic and mediastinal disorders0/121/120/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ticagrelor 45mgTicagrelor 60mgTicagrelor 90mgTotal
Mean59.3 ± 9.861.3 ± 7.057.9 ± 12.659.5 ± 9.9
Age, Customized
Age, Customized(Participants)Ticagrelor 45mgTicagrelor 60mgTicagrelor 90mgTotal
< 65 years98825
>=65 years34411
Sex: Female, Male
Sex: Female, Male(Participants)Ticagrelor 45mgTicagrelor 60mgTicagrelor 90mgTotal
Female3238
Male910928
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ticagrelor 45mgTicagrelor 60mgTicagrelor 90mgTotal
Hispanic or Latino0000
Not Hispanic or Latino12121236
Unknown or Not Reported0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Ticagrelor 45mgTicagrelor 60mgTicagrelor 90mgTotal
Asian12121236
08

Study locations

1 site
  • Research Site
    Beijing, China
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.

Results were first posted in May 2016, 1 year 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2014
First posted
Feb 17, 2014
Start
Feb 2014
Primary completionActual
Nov 2014
CompletionActual
Nov 2014
Results first posted
May 11, 2016
Last update
May 11, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02064985
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Feb 17, 2014
Start date
Feb 2014
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
May 11, 2016
Last update
May 11, 2016

Study contacts

Haiyan Li, PhD
principal investigator · The 3rd Hospital of Peking University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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