Phase 3
N=13,608
A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Coronary Arteriosclerosis · Acute Coronary Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00097591 ↗Enrolled (actual)
13,608
Serious AEs
25.3%
Results posted
Sep 2010
Primary outcome: Primary: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke — 469; 565; 174; 216 Participants — p=0.002
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
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke |
389; 502; 462; 573 | <0.001 sig |
| SECONDARY Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events |
303; 231; 146; 111; 85; 56 | 0.002 sig |
| SECONDARY Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) |
399; 504; 472; 588 | <0.001 sig |
| SECONDARY Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke |
389; 502; 462; 573 | <0.001 sig |
| SECONDARY Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events |
797; 938 | <0.001 sig |
| SECONDARY Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke |
692; 822 | <0.001 sig |
Summary
The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
Eligibility Criteria
Inclusion Criteria
- A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.
- A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
- If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.
Exclusion Criteria
- A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
- A person who has active internal bleeding or has a history of a bleeding disorder.
- Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
- A person who has liver disease; for example, cirrhosis.
- A person who has a condition such as alcoholism, mental illness, or is drug dependent.
- A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).
Data sourced from ClinicalTrials.gov (NCT00097591). 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.