PLAVIX Efficacy
PLAVIX Monotherapy

PLAVIX Efficacy - The CAPRIE Trial

The CAPRIE Trial demonstrated that PLAVIX reduced the risk of myocardial infarction (MI), ischemic stroke, or vascular death 11, 17

Efficacy of PLAVIX vs. Aspirin in Reducing the combined risk of Myocardial Infarction (MI), Ischemic Stroke, and Vascular Death in patients with recent stroke, recent MI, or established PAD (CAPRIE chart)

  • 19,185 patients from 384 centers in 16 countries 11, 17
  • PLAVIX 75 mg/day vs aspirin 3 5 mg 11, 17
  • Recent MI (≥35 days) patients included those with non-ST-segment elevation MI and ST-segment elevation 11, 17
  • First antiplatelet study to include patients with three clinical manifestations of atherothrombosis in the same trial 11, 17

The results of the CAPRIE trial established PLAVIX (clopidogrel bisulfate) as more effective than aspirin in reducing the combined risk of MI, ischemic stroke, and vascular death in patients with atherosclerotic vascular disease. 1 In the CAPRIE trial, PLAVIX demonstrated an 8.7% (P=0.045) relative risk reduction compared to aspirin in the combined end points of MI, ischemic stroke, and vascular death. 18

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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Due to an expected reduction in drug levels and clinical efficacy, concomitant use of drugs that inhibit CYP2C19 (eg, omeprazole) should be discouraged. (See PRECAUTIONS.*)

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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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Based on literature, patients with genetically reduced CYP2C19 function have diminished responses and generally exhibit higher CV event rates following MI. (See PRECAUTIONS.*)

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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.*)