A Phase 2 interventional study of Prasugrel and Clopidogrel in Coronary Artery Disease (CAD), sponsored by Eli Lilly and Company. Terminated at 27 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-08.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.
To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents.
To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 423 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Exclusion Criteria:
Drug: Prasugrel
Drug: Clopidogrel
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
Also known as: LY640315, Effient, Efient
75 mg oral daily maintenance dose up to 6 months.
Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
The endpoint in this measure is a combination of cardiovascular death or MI.
Time frame: Baseline through 6 months
Number of Participants With Stent Thrombosis (ST)
Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.
Time frame: Baseline through 6 months
Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)
The endpoint in this measure is a combination of all-cause death or MI.
Time frame: Baseline through 6 months
| Milestone | Prasugrel | Clopidogrel |
|---|---|---|
| Started | 212 | 211 |
| Received at least 1 dose of study drug | 210 | 210 |
| Completed | 136 | 137 |
| Not completed | 76 | 74 |
| Withdrew: Withdrawal by subject | 16 | 13 |
| Withdrew: Sponsor decision | 58 | 60 |
| Withdrew: Didn't receive any study drug | 2 | 1 |
The endpoint in this measure is a combination of cardiovascular death or MI.
| participants | Prasugrel | Clopidogrel |
|---|---|---|
| Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI) | 0 | 1 |
Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.
| participants | Prasugrel | Clopidogrel |
|---|---|---|
| Number of Participants With Stent Thrombosis (ST) | 0 | 0 |
The endpoint in this measure is a combination of all-cause death or MI.
| participants | Prasugrel | Clopidogrel |
|---|---|---|
| Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI) | 0 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prasugrel | — | 40/210 (19%) | 110/210 (52.4%) |
| Clopidogrel | — | 38/210 (18.1%) | 72/210 (34.3%) |
| Event | Prasugrel | Clopidogrel |
|---|---|---|
| Angina pectorisCardiac disorders | 6/210 | 2/210 |
| Non-cardiac chest painGeneral disorders | 2/210 | 5/210 |
| Hypertensive crisisVascular disorders | 3/210 | 2/210 |
| Cardiac failureCardiac disorders | 1/210 | 2/210 |
| ContusionInjury, poisoning and procedural complications | 0/210 | 2/210 |
| Aortic aneurysmVascular disorders | 0/210 | 2/210 |
| Angina unstableCardiac disorders | 0/210 | 1/210 |
| ArrhythmiaCardiac disorders | 1/210 | 0/210 |
| Atrial fibrillationCardiac disorders | 0/210 | 1/210 |
| Atrioventricular block second degreeCardiac disorders | 0/210 | 1/210 |
| Event | Prasugrel | Clopidogrel |
|---|---|---|
| EpistaxisRespiratory, thoracic and mediastinal disorders | 20/210 | 8/210 |
| NasopharyngitisInfections and infestations | 15/210 | 8/210 |
| ContusionInjury, poisoning and procedural complications | 7/210 | 2/210 |
| Spontaneous haematomaBlood and lymphatic system disorders | 6/210 | 2/210 |
| DiarrhoeaGastrointestinal disorders | 3/210 | 6/210 |
| PruritusSkin and subcutaneous tissue disorders | 6/210 | 1/210 |
| Traumatic haematomaInjury, poisoning and procedural complications | 4/210 | 4/210 |
| Atrial fibrillationCardiac disorders | 2/210 | 3/210 |
| NauseaGastrointestinal disorders | 2/210 | 3/210 |
| Oedema peripheralGeneral disorders | 3/210 | 2/210 |
| Age Continuous(years) | Prasugrel | Clopidogrel | Total |
|---|---|---|---|
| Mean | 65.8 ± 8.3 | 66.3 ± 8.6 | 66.1 ± 8.4 |
| Sex: Female, Male(Participants) | Prasugrel | Clopidogrel | Total |
|---|---|---|---|
| Female | 59 | 57 | 116 |
| Male | 153 | 154 | 307 |
| Race/Ethnicity, Customized(participants) | Prasugrel | Clopidogrel | Total |
|---|---|---|---|
| Asian | 1 | 1 | 2 |
| Black or African American | 0 | 3 | 3 |
| White | 211 | 207 | 418 |
| Region of Enrollment(participants) | Prasugrel | Clopidogrel | Total |
|---|---|---|---|
| United States | 12 | 13 | 25 |
| Germany | 200 | 198 | 398 |
This study is terminated, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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