PLAVIX Clinical Trials

PLAVIX was utilized in four trials to study a broad population of 81,000 patients at risk for future atherothrombotic events

PLAVIX Clinical Trials for patients at risk for atherothrombotic events (chart)

* For patients who did not undergo angiography, the primary end point was death or recurrent MI by day 8 or by hospital discharge if prior to day 8.

  • CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) was a randomized, blinded clinical trial of 19,185 patients from 384 centers in 16 countries to assess the potential benefit of clopidogrel (75 mg) compared with aspirin (325 mg) in reducing the risk of ischemic stroke, myocardial infarction (MI), or vascular death in patients with recent ischemic stroke, recent MI, or peripheral arterial disease (PAD) 15
  • CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) was a randomized, double-blind, placebo-controlled, multicenter study of 12,562 men and women from 482 centers in 28 countries presenting within 24 hours of acute chest pain or symptoms consistent with ischemia. Patients diagnosed with ACS were randomized to a 300 mg PLAVIX oral loading dose followed by 75 mg PLAVIX once daily or to placebo for up to 1 year (mean: 9 months). All patients received aspirin (75 mg - 325 mg) 15
  • COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) was a randomized, double-blind, placebo-controlled trial with a 2x2 factorial design. In all, 45,852 patients from 1,250 centers in China presenting within 24 hours of the onset of symptoms of suspected MI with supporting ECG abnormalities (ie, ST elevation, ST depression, or left bundle branch block) were randomized to receive PLAVIX 75 mg once daily or placebo in combination with aspirin (162 mg) until hospital discharge or up to 28 days (mean duration of treatment in survivors: 15 days). Patients undergoing percutaneous coronary intervention (PCI) were excluded from the trial 15
  • CLARITY (CLopidogrel as Adjunctive ReperfusIon TherapY) was a randomized, double-blind, placebo-controlled trial of 3,491 patients from 319 centers in 23 countries presenting within 12 hours of the onset of ST-segment elevation acute MI who were scheduled to receive thrombolytic therapy. Patients were randomized to receive a PLAVIX 300 mg loading dose, followed by PLAVIX 75 mg once daily or placebo up to the day of angiography. Those not receiving angiography received treatment up to day 8 or discharge, whichever came first. All patients received aspirin (150 mg - 325 mg on the first day and 75 mg-162 mg/day thereafter). Patients were followed for 30 days 15
Indications
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Use PLAVIX plus aspirin for patients with non–ST–segment elevation acute coronary syndrome (UA/non–Q–wave MI), including patients to be managed medically and those to be managed with percutaneous coronary intervention (with or without stent) or CABG, to decrease the rate of a combined end point of CV death, MI, or stroke as well as the rate of a combined end point of CV death, MI, stroke, or refractory ischemia.

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Use PLAVIX plus aspirin for patients with ST–segment elevation acute myocardial infarction to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

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Use PLAVIX alone for patients with a history of recent stroke, recent MI, or established PAD to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Important Risk Information 18
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PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.*)

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The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo
plus aspirin in clinical trials. (See ADVERSE REACTIONS.*)

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As part of the worldwide post–marketing experience with PLAVIX, there have been cases of reported thrombotic thrombocytopenic purpura (TTP), some with fatal outcome. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). (See WARNINGS.*)

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In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)