Problem ACS (excluding STEMI)
Format Double-blinded multi-center RCT
Treatment Clopidogrel
Control Placebo
Population 12562 patients within 24hrs of ACS without ST-elevation
Inclusion criteria Patients were eligible for the study if they had been hospitalized within 24 hours after the onset of symptoms and did not have ST-segment elevation. Initially, patients older than 60 years of age with no new electrocardiographic changes but with a history of coronary artery disease were included. However, after a review of the overall rates of events among the first 3000 patients, the steering committee recommended that we enroll only patients who had either electrocardiographic changes or an elevation in the serum level of cardiac enzymes or markers at entry.
Exclusion criteria We excluded patients with contraindications to antithrombotic or antiplatelet therapy, those who were at high risk for bleeding or severe heart failure, those who were taking oral anticoagulants, and those who had undergone coronary revascularization in the previous three months or had received intravenous glycoprotein IIb/IIIa receptor inhibitors in the previous three days.
Follow-up 3 - 12 months
Primary endpoint Composite of death from cardiovascular causes, nonfatal MI or stroke

Composite of the first primary outcome or refractory ischemia
Secondary endpoint(s) The secondary outcomes were severe ischemia, heart failure, and the need for revascularization. The safety-related outcomes were bleeding complications, which were categorized as life-threatening, major (requiring the transfusion of 2 or more units of blood), or minor.
Details Both sets received aspirin
Brief summary: Proved benefit of clopidogrel added to aspirin in NSTEMI/UA
PAPER: Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation.
Date 16 Aug 2001
Journal N Engl J Med. 2001 Aug 16;345(7):494-502.
Information Clopdigrel & Aspirin (vs. aspirin + placebo)
-Reduced composite of death from cardiovascular causes, non-fatal MI, or stroke
-Reduced composite of above or refractory ischaemia
-Increased major and minor bleeding