TRITON-TIMI 38
A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
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Status:
Completed. Results published November 2007.
Purpose:
To test prasugrel (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) and compare it to clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
Location(s):
30 countries
Year Started:
2004
Year Presented:
2007
Design:
Interventional, treatment, randomized, double-blind, active control, parallel assignment, safety/efficacy study.
Inclusion Criteria
Patients diagnosed with acute coronary syndrome and are to undergo a percutaneous intervention; woman of childbearing potential (i.e., before menopause) must test negative for pregnancy and agree to use a reliable method of birth control.
Exclusion Criteria
Patients who had a stroke within the last 3 months; active internal bleeding or have a history of a bleeding disorder; individuals at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician; liver disease; conditions such as alcoholism, mental illness, or drug dependency.
Patient Involvement:
Patients were randomized to receive prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose) for 6 to 15 months.
Primary Outcome:
Number of cardiovascular (CV) deaths, nonfatal myocardial infarctions (MI), or nonfatal strokes at a median follow-up of at least 12 months.
Secondary Outcome:
Number of incidence of major and minor bleeding events to evaluate overall safety and tolerability of CS-747.
Results:
A total of 781 patients (12.1%) in the clopidogrel group had the primary end point, as compared with 643 patients (9.9%) in the prasugrel group (P<0.001). There were reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001).
Fatal bleeding occurred in 0.4% of patients treated with prasugrel compared to 0.1% of those treated with clopidogrel (P = 0.002), and nonfatal life-threatening bleeding occurred in 1.1% of the prasugrel group vs. 0.9% in the clopidogrel group (P = 0.23). Intracranial hemorrhage was reported in 19 patients (0.3%) receiving prasugrel and 17 patients (0.3%) receiving clopidogrel (P = 0.74).
Source of Information:
Am Heart J 2006;152:627-35.
N Engl J Med 2007;357:2001-15.
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This information last updated on: 11/4/2007
Reviewed on: 05/07/2009.
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