Phase 2
N=201
Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00357968 ↗Enrolled (actual)
201
Serious AEs
6.2%
Results posted
Aug 2010
Primary outcome: Primary: Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose — 74.81; 31.77 percent inhibition — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prasugrel (Drug); Clopidogrel (Drug); Placebo for Prasugrel (Drug); Placebo for Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose |
74.81; 31.77 | <0.0001 sig |
| PRIMARY Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment |
61.34; 46.06 | <0.0001 sig |
| SECONDARY Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose |
64.54; 20.32 | <0.0001 sig |
| SECONDARY Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase |
2; 0 | — |
| SECONDARY Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase |
0; 0 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase |
2; 1 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase |
1; 0 | — |
| SECONDARY Number of Hyporesponsive Participants at 6 Hours After the Loading Dose |
0; 21 | <0.0001 sig |
| SECONDARY Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase |
1; 7 | 0.0629 |
| SECONDARY Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase |
4; 1 | 0.1827 |
| SECONDARY Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose |
21.5; 75.0 | <0.0001 sig |
| SECONDARY Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose |
7.4; 68.4 | <0.0001 sig |
| SECONDARY Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose |
10.3; 64.3 | <0.0001 sig |
| SECONDARY Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment |
23.4; 43.8 | <0.0001 sig |
| SECONDARY Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose |
9.16; 8.13 | 0.7058 |
| SECONDARY Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose |
11.64; 11.16 | 0.4029 |
| SECONDARY Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose |
0.06; 0.05 | 0.7893 |
| SECONDARY Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose |
0.12; 0.13 | 0.4528 |
Summary
The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).
Eligibility Criteria
Inclusion Criteria
- Subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
- At least one of the following (a through c):
- Functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
- A reversible defect on nuclear imaging.
- A reversible wall-motion abnormality by echocardiography.
- Horizontal or down-sloping ST-depressions greater than 1 mm on electrocardiogram (ECG) (if no imaging performed).
- Prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
- A cardiac catheterization with at least one coronary artery lesion amenable to PCI (not yet performed) within 14 days prior to enrollment.
Exclusion Criteria
- Known creatine kinase-myocardial bands (CK-MB)or cardiac troponin greater than the upper limit of normal at time of screening
- Planned PCI for acute myocardial infarction (MI) or planned PCI within 48 hours of fibrinolytic therapy for ST segment elevation myocardial infarction (STEMI)
- Have cardiogenic shock at the time of screening (systolic blood pressure 90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
- Refractory ventricular arrhythmias
- Have New York Heart Association Class IV congestive heart failure
Data sourced from ClinicalTrials.gov (NCT00357968). 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.