Phase 3
N=719
A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00830960 ↗Enrolled (actual)
719
Serious AEs
6.4%
Results posted
Nov 2011
Primary outcome: Primary: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years) — 88.5; 124.2; 261.8 PRU — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Prasugrel (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years) |
88.5; 124.2; 261.8 | <0.0001 sig |
| PRIMARY Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort |
71.6; 99.3; 150.8; 206.5 | <0.0001 sig |
| SECONDARY Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts. |
250.5; 280.4; 312.1; 311.2; 379.5; 116.9 | 0.0058 sig |
| SECONDARY Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort |
71.6; 99.3; 150.8; 206.5; 134.2; 237.5 | <0.0001 sig |
| SECONDARY Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort |
10; 4; -5; 11; 0; 49 | 0.0072 sig |
| SECONDARY Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort |
67; 60; 45; 29; 68; 32 | <0.0001 sig |
| SECONDARY Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke |
— | — |
| SECONDARY Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) |
— | — |
| SECONDARY Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization |
— | — |
| SECONDARY Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually) |
— | — |
| SECONDARY Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition |
— | — |
| SECONDARY Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition |
— | — |
| SECONDARY Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort |
5; 4; 3; 2; 7; 1 | 0.255 |
| SECONDARY Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding |
2; 0; 0; 0; 2; 2 | — |
| SECONDARY Incidence of CABG-related TIMI Major or Minor Bleeding. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Inpatient Healthcare Resource Utilization |
— | — |
| SECONDARY Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary |
-162.9; -198.8; -217.2; -9.7; -245.9; -183.3 | — |
| SECONDARY Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually) |
— | — |
Summary
The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.
Eligibility Criteria
Inclusion Criteria
- A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
- A person who is of East or Southeast Asian descent
- A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study
- If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control
Exclusion Criteria
- A person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure
- A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
- A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA)
- A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
- A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
- A person who has a severe liver disease, such as cirrhosis
- A person who has a condition such as alcoholism, mental illness, or drug dependence
Data sourced from ClinicalTrials.gov (NCT00830960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.