Phase 2
N=905
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Cardiovascular Diseases · Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00059215 ↗Enrolled (actual)
905
Serious AEs
7.3%
Results posted
May 2010
Primary outcome: Primary: Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events — 3; 4; 4; 3 participants — p=0.933
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prasugrel (CS-747) (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events |
3; 4; 4; 3; 11 | 0.933 |
| SECONDARY Number of Participants With Major Adverse Cardiovascular Events (MACE) |
15; 15; 17; 24; 47 | 0.945 |
| SECONDARY Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding |
1; 1; 1; 2; 3 | 1.0 |
| SECONDARY Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE |
17; 19; 20; 27; 56 | 0.370 |
Summary
The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.
Eligibility Criteria
Inclusion Criteria
- Patients must be candidates for elective or urgent PCI with intended coronary stenting.
- Men or non-pregnant women (that is, postmenopausal women, women who are surgically sterile, or women of childbearing potential who have a negative urine or serum pregnancy test) who are greater than or equal to 18 and less than or equal to 75 years of age.
Exclusion Criteria
- Patients must not have planned PCI procedure as initial treatment for an acute ST-elevation acute myocardial infarction (STEMI)
- Patients must not be receiving or will receive oral anticoagulation therapy that cannot be safely discontinued for the duration of the study
- Patients must not have cardiogenic shock or severe congestive heart failure
- Patients must not have active internal bleeding or history of bleeding diathesis
- Patients must not have prior history of hemorrhagic cerebrovascular accident (CVA) or nonhemorrhagic CVA within 2 years of enrollment
Data sourced from ClinicalTrials.gov (NCT00059215). 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.