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WithdrawnNCT01757262Updated May 13, 2013

A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient

A Phase 3 interventional study of 90 mg Ticagrelor and 75mg Clopidogrel in Coronary Heart Disease, sponsored by AstraZeneca. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-13.

Sponsored by AstraZeneca · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel

Read the detailed description

Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients with Coronary Heart Disease: A Randomized, Open Label, Crossover Study

02

Conditions studied

  • Coronary Heart Disease

Keywords

  • Coronary Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

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

Inclusion criteria

  • Male or female Vietnamese patients (as confirmed by the Principal Investigator) aged >18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease
  • Stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period
  • Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive
  • Women must have a negative urine pregnancy test at Visit 1

Exclusion criteria

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
  • Unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
  • Patients who had acute coronary syndrome or stent placed within 12 months of screening
  • Planned arterial revascularization
  • Current use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol
05

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Ticagrelor

    90 mg Ticagrelor

    Drug: 90 mg Ticagrelor

  • Active comparator
    Clopidogrel

    75mg Clopidogrel

    Drug: 75mg Clopidogrel

Interventions

  • Drug90 mg Ticagrelor

    Morning and Evening dose for 5 days

  • Drug75mg Clopidogrel

    Morning dose for 5 days

06

What researchers measure

Primary outcomes

  1. Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]

    Time frame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5

  2. Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]

    Time frame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5

Secondary outcomes

  1. Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables

    Time frame: From screening to followup (8 weeks)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01757262
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 28, 2012
Start date
Jan 2013
Primary completion
Apr 2013 (estimated)
Completion
Apr 2013 (estimated)
Last update
May 13, 2013

Study contacts

Nguyen Lan Viet, MD
principal investigator · National Heart Institute, Bach Mai Hospital, Vietnam
Judith Hsia, MD
study director · Astrazeneca, Wilmington, US
Miriana Kujacic, MD
study chair · Astrazeneca, Molndal, Sweden
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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