Clopidogrel plus aspirin in patients with acute myocardial infarction treated with fibrinolytic therapy--CLARITY-TIMI 28.
Evaluation of: Sabatine MS, Cannon CP, Gibson CM et al.: CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N. Engl. J. Med. 352, 1179-1789 (2005). The CLopiodogrel as Adjunctive ReperfusIon TherapY (CLARITY)--Thrombolysis In Myocardial Infarction (TIMI) 28 study was a double-blind, placebo-controlled trial designed to evaluate whether the addition of clopidogrel to aspirin would improve infarct artery patency and reduce ischemic complications in patients with acute myocardial infarction (MI) treated with fibrinolytic therapy. A total of 3491 patients presenting within 12 h of MI intended for treatment with a fibrinolytic agent were enrolled and randomized to receive either aspirin alone or aspirin plus clopidogrel (300 mg loading dose followed by 75 mg/day). The primary efficacy end point was the composite of the presence of an occluded infarct-related artery (TIMI flow grade 0 or 1) at follow-up angiography (performed 48-192 h after enrollment), or death or recurrent MI before angiography; this occurred in 21.7% of the placebo group and 15.0% of the clopidogrel group (p < 0.001). At 30 days, the composite of death, MI and recurrent ischemia requiring revascularization was 14.1% in the placebo group and 11.6% in the clopidogrel group (p = 0.03). The primary safety end point was the incidence of major bleeding (by TIMI criteria); other safety end points included intracranial hemorrhage and TIMI minor bleeding. There were no significant differences in bleeding events between groups.
Ferguson
James J
JJ
Cardiology Research, Mail Code 1-191, St Luke's Episcopal Hospital, 6720 Bertner Ave, Houston, TX 77030, USA. jferguson@heart.thi.tmc.edu