CTRI/2010/091/000348
Completed
Phase 2
A Comparison of Platelet Inhibition Following a Prasugrel 60 mg or Prasugrel 30 mg Loading Dose With or Without Pretreatment With a Clopidogrel Loading Dose in Acute Coronary Syndrome Patients Who Are to Undergo Percutaneous Coronary Intervention
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Eli Lilly
- Enrollment
- 210
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Present with acute coronary syndrome (ACS) consisting of unstable angina (UA), Non ST\-elevated myocardial infarction (NSTEMI)or ST\-elevated myocardial infarction (STEMI) and are to undergo percutaneous coronary intervention (PCI).
- •\-Provide written informed consent (ICD) by participant or authorized representative
- •\-Weigh at least 60 kilograms at the time of screening.
- •\-For women of child\-bearing potential (that is, women who are not surgically or chemically sterilized and who are between menarche and 1 year postmenopause), test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study.
- •\-Sign ICD for mandatory genetic testing.
Exclusion Criteria
- •Cardiovascular Exclusion Criteria
- •\-Have cardiogenic shock at the time of randomization (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.
- •\-Have refractory ventricular arrhythmias
- •\-Have New York Heart Association (NYHA) Class IV congestive heart failure
- •\-Have systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 100 mm Hg.
- •\-Have received fibrin\-specific fibrinolytic therapy \<24 hours prior to randomization.
- •\-Have received nonfibrin\-specific fibrinolytic therapy \<48 hours prior to randomization.
- •\-Have active internal bleeding or history of bleeding diathesis.
- •\-Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
- •\-Prior history of ischemic or hemorrhagic stroke.
Outcomes
Primary Outcomes
Not specified
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