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CompletedNCT01575795Updated Apr 10, 2013

Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

A Phase 4 interventional study of Ticagrelor and Ticagrelor in ST-elevation Myocardial Infarction, sponsored by University of Patras. Completed at 1 site in Greece. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2013-04-10.

Sponsored by University of Patras · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
01

Study summary

This is a multi-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, performed at 3 institutions (Patras University Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).

Patients with ST elevation myocardial infarction (symptom onset \< 12 hours), undergoing primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary intervention, will be randomized after informed consent, in a 1:1 ratio to either:

Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6 hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow assay, in platelet reactivity units (PRU).

Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic Research Consortium criteria) will be performed until patient's discharge.

02

Conditions studied

  • ST-elevation Myocardial Infarction

Keywords

  • Ticagrelor
  • ST elevation acute myocardial infarction
  • Platelet reactivity
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 83 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

University of Patras is the lead sponsor of 69 studies on the registry; 10 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old
  2. Patients with STEMI (onset of pain \< 12 hours) with indication for primary PCI
  3. Antiplatelet naïve or presenting HTPR (≥ 208 PRU) immediately before primary percutaneous coronary intervention
  4. Informed consent obtained in writing

Exclusion criteria

Exclusion Criteria

  • Pregnancy
  • Breastfeeding
  • Inability to give informed consent or high likelihood of being unavailable until the Day 5
  • Cardiogenic shock
  • Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
  • Unsuccessful PCI (residual stenosis > 30% or flow \< ΤΙΜΙ 3)
  • Known hypersensitivity to ticagrelor
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
  • Any previous history of stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  • Thrombocytopenia (\< 100.000/μL) at randomization
  • Anaemia (Hct \< 30%) at randomization
  • Polycytaemia (Hct > 52%) at randomization
  • Periprocedural IIb/IIIa inhibitors administration
  • Thrombolysis administration
  • Recent (\< 6 weeks) major surgery or trauma, including GABG.
  • Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
  • Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin/rifampicin, phenytoin, carbamazepine).
  • Increased risk of bradycardiac events.
  • Dialysis required.
  • Severe uncontrolled chronic obstructive pulmonary disease
  • Known severe hepatic impairment
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
83 participants (actual)

Study arms

  • Active comparator
    Ticagrelor 180mg loading dose

    Ticagrelor 180mg loading dose

    Drug: Ticagrelor

  • Experimental
    Ticagrelor 360mg loading dose

    Ticagrelor 360mg loading dose

    Drug: Ticagrelor

Interventions

  • DrugTicagrelor

    Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose

  • DrugTicagrelor

    Ticagrelor 180mg loading dose 180mg loading dose

06

What researchers measure

Primary outcomes

  1. platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.

    platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.

    Time frame: 1 hour

Secondary outcomes

  1. 1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.

    1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.

    Time frame: 1 hour

  2. 2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B

    Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B

    Time frame: 0.5 hour

  3. Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B

    Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B

    Time frame: 2 hours

  4. Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B

    Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B

    Time frame: 4 hours

  5. 3. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B

    High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B

    Time frame: 0.5 hour

  6. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B

    High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B

    Time frame: 1 hour

  7. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B

    High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B

    Time frame: 2 hours

  8. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B

    High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B

    Time frame: 4 hours

  9. Occurrence of any 5-day bleeding event (BARC Types 1-5)

    Occurrence of any 5-day bleeding event (BARC Types 1-5)

    Time frame: 5 days

  10. Occurrence of 5-day MACEs

    Occurrence of 5-day MACEs

    Time frame: 5 days

07

Study locations

1 site
  • Cardiology Department Patras University Hospital
    Rio, Achaia 26500, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01575795
Lead sponsor
University of Patras
Responsible party
Dimitrios Alexopoulos (Professor, University of Patras) — Principal investigator
First posted
Apr 11, 2012
Start date
Apr 2012
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Apr 10, 2013

Study contacts

Dimitrios Alexopoulos, MD
principal investigator · University Hospital of Patras

Oversight

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

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