PLAVIX Efficacy
PLAVIX with Aspirin

PLAVIX Efficacy - CURE Trial

The CURE Trial demonstrated that PLAVIX with aspirin reduced the risk of myocardial infarction (MI), stroke, or cardiovascular death, regardless of intervention 14, 17

Efficacy of PLAVIX + Aspirin vs. Aspirin + Placebo in Reducing the combined risk of Myocardial Infarction (MI), Ischemic Stroke, and Vascular Death in UA/NSTEMI (CURE chart)

  • Randomized, double-blind, placebo-controlled, multicenter study
  • 12,562 patients from 48 centers in 8 countries randomized ≤ 24 hours of symptom onset 14, 17
  • 300 mg PLAVIX loading dose; maintenance therapy: PLAVIX 75 mg + aspirin 75 mg-3 5 mg vs placebo + aspirin 75 mg-3 5 mg 14, 17
  • 36% of patients received intervention (percutaneous transluminal coronary angioplasty [PTCA] and/or CABG), 64% were managed without intervention 17
  • In patients taking PLAVIX in whom elective CABG is planned, the drug should be withheld for 5 to 7 days 14, 17
  • The benefit of PLAVIX with aspirin was independent of other acute and long-term cardiovascular risk-reducing therapies, including statins, ACE inhibitors, and beta-blockers 14, 17

PLAVIX Efficacy - COMMIT Trial

The COMMIT Trial demonstrated that PLAVIX with aspirin significantly reduced the risk of all-cause mortality, death, reinfarction, or stroke 17

Efficacy of PLAVIX + Aspirin vs. Aspirin + Placebo in Reducing the risk of all-cause mortality in STEMI (COMMIT chart)

  • PLAVIX with aspirin also significantly reduced the relative risk of the combined end point of death, reinfarction, or stroke by 9% vs placebo with aspirin (P=0.00) 17
  • — The primary combined outcome occurred in 9.2% of patients in the PLAVIX aspirin group and 10.1% in the placebo + aspirin group
  • — Only first relevant events during the scheduled treatment period were counted in the composite end point
  • 45,852 patients from 1,250 centers randomized ≤24 hours of symptom onset 17
  • Patients were managed with PLAVIX 75 mg/day + aspirin 162mg vs placebo + aspirin 16 mg: 17
  • — Patients who underwent primary percutaneous coronary intervention (PCI) were excluded
  • — Mean duration of treatment: 15 days
  • — 55% received fibrinolytics
  • The effect of PLAVIX did not differ significantly in various prespecified subgroups 17
  • The benefits of PLAVIX 75 mg daily seemed to emerge rapidly

PLAVIX Efficacy - CLARITY Trial

The CLARITY Trial demonstrated that PLAVIX with aspirin reduced the odd of occlusion in the infarct-related artery on predischarge angiography; or death or recurrent myocardial infarction (MI) before angiography13,15†

Efficacy of PLAVIX + Aspirin vs. Placebo + Aspirin for reducing odds of occlusion in the infarct-related artery, death, or recurrent Myocardial Infarction (MI) before angiography in STEMI (CLARITY chart)

  • 3,491 patients from 319 centers randomized ≤12 hours of symptom onset 17
  • PLAVIX 300 mg loading dose, followed by PLAVIX 75 mg/day + aspirin vs placebo + aspirin 17
  • — All patients received aspirin (150 mg-325 mg on the first day and 75 mg-162 mg/day thereafter) 17
  • — Median time to PLAVIX 300 mg loading dose: 2.9 hours
  • — 99.7% of patients received fibrinolytic therapy 17
  • For the PLAVIX + aspirin group, 63% of patients underwent subsequent revascularization 17
  • — 57% of percutaneous coronary intervention (PCI)
  • — 6% of coronary artery bypass graft (CABG)
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.*)