Clopidogrel before percutaneous coronary intervention reduced cardiovascular outcome in ST-elevation myocardial infarction.

M e t h o d s Design: Planned subanalysis of a randomized placebo-controlled trial (PCI-Clopidogrel as Adjunctive Reperfusion Therapy [CLARITY]-Thrombolysis in Myocardial Infarction [TIMI] 28 trial [CLARITY-TIMI 28]). Allocation: {Concealed}†.* Blinding: Blinded (clinicians, patients, {data collectors, clinical events committee, and data analysts}†).* Follow-up period: 30 days. Setting: 319 sites in 23 countries. Patients: 1863 patients 18 to 75 years of age (mean age 57 y, 82% men) with onset of ischemic discomfort at rest ≤ 12 hours and lasting ≥ 20 minutes; ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous limb leads, ≥ 0.2 mV in ≥ 2 contiguous precordial leads, or new left bundle-branch block; and planned treatment with a fibrinolytic, anticoagulant, and aspirin. Exclusion criteria were clopidogrel in the previous 7 days, clopidogrel or glycoprotein IIb/IIIa inhibitor planned before angiography, contraindication to fibrinolysis, angiography planned within 48 hours, cardiogenic shock, previous coronary artery bypass grafting, or bolus of any heparin at greater than standard doses. Intervention: Clopidogrel, 300 mg followed by 75 mg/d (n = 933) or placebo (n = 930) up to the time of angiography. All patients received aspirin, 150 to 325 mg followed by 75 to 162 mg/d, or unfractionated heparin for 48 hours (60 U/kg intravenous bolus [maximum 4000 U] followed by an infusion of 12 U/kg per h [maximum 1000 U/h]), and coronary angiography 2 to 8 days after starting medication. It was recommended that patients having PCI receive open-label clopidogrel with a loading dose at the time of PCI. Outcomes: Composite endpoint of cardiovascular death, recurrent MI, or stroke from PCI to 30 days after randomization. Secondary outcomes were recurrent MI or stroke before PCI, the composite endpoint from randomization to 30 days, and TIMI major or minor bleeding. Patient follow-up: 99.9% (intention-to-treat analysis).