Efficacy


PLAVIX Living Proof means proven efficacy and a well established safety profile

PLAVIX is the only prescription antiplatelet with proven efficacy and a well established safety profile in a broad range of patients.

Proven Effectiveness

CAPRIE Trial


8.7% Relative Risk Reduction (P=0.045) in Patients with recent myocardial infarction (MI), recent ischemic stroke, or established peripheral arterial disease (PAD) for up to 3 years1,3

  • N=19,185
  • PLAVIX 75 mg vs. aspirin 325 mg
  • Combined end point: MI, ischemic stroke, or vascular death
  • Event rate: 9.8% for PLAVIX vs. 10.6% for aspirin

Although the statistical significance favoring PLAVIX over aspirin was marginal (P=0.045) and represents the result of a single trial that has not been replicated, the comparator drug, aspirin, is itself effective (vs. placebo) in reducing CV events in patients with recent MI or stroke. Thus, the difference between PLAVIX and placebo, although not measured directly, is substantial.

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CURE Trial


20% Relative Risk Reduction (P=0.00009) in ACS† patients with unstable angina (UA)/non-ST-segment elevation MI (NSTEMI) (onset ≤24 hours; with loading dose‡) for up to 1 year1,4

  • N=12,562
  • PLAVIX 75 mg + aspirin 75 to 325 mg vs. placebo + aspirin 75 to 325 mg
  • Combined end point: MI, stroke, or CV death independent of standard CV therapies with or without percutaneous transluminal coronary angioplasty (PTCA) and/or coronary artery bypass graft (CABG)
  • Event rate: 9.3% for PLAVIX + aspirin vs. 11.4% for placebo + aspirin
  • In the co-primary combined end point of MI, stroke, CV death or refractory ischemia, the relative risk reduction (RRR) was 14% (16.5% vs. 18.8%; P=0.0005). Only first events after randomization were counted in the composite end point.

†ACS=acute coronary syndrome (UA [unstable angina], NSTEMI, STEMI)

‡Patients in the PLAVIX + aspirin arm were randomized to a 300 mg PLAVIX loading dose followed by 75 mg PLAVIX once daily

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COMMIT Trial


7% Relative Risk Reduction (P=0.029) in ACS patients with STEMI (onset ≤24 hours) up to 28 days1,6

  • N=45,852
  • PLAVIX 75 mg + aspirin 162 mg vs. placebo + aspirin 162 mg
  • Primary end point: all-cause mortality up to 28 days or hospital discharge
  • Event rate: 7.5% for PLAVIX + aspirin vs. 8.1% for placebo + aspirin
  • PLAVIX with aspirin also significantly reduced the relative risk of the co-primary combined end point of death, reinfarction, or stroke by 9% vs. placebo with aspirin (9.2% vs. 10.1%; P=0.002). Only first relevant events during the scheduled treatment period were counted in the composite end point. Patients who underwent percutaneous coronary intervention (PCI) were excluded.

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CLARITY Trial


36% Odds Reduction (P<0.001) in ACS patients with STEMI (onset ≤12 hours; with loading dose‡) up to 8 days1,7

  • N=3,491
  • PLAVIX 75 mg + aspirin 75 to 162 mg vs. placebo + aspirin 75 to 162 mg
  • Primary end point: composite of an occluded infarct-related artery on the predischarge angiography, or death or recurrent MI before angiography, discharge, or day 8, whichever came first
  • Event rate: 15% for PLAVIX + aspirin vs. 21.7% for placebo + aspirin
  • Most of the events were related to the surrogate end point of vessel patency. Patients were scheduled to undergo angiography 48 to 192 hours after the start of study medication.

‡Patients in the PLAVIX + aspirin arm were randomized to a 300 mg PLAVIX loading dose followed by 75 mg PLAVIX once daily

Learn more about the CLARITY Trial

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Important Risk Information

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.*)

The metabolism of PLAVIX can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19 (eg,omeprazole), causing reduced effectiveness. Avoid use of PLAVIX in patients with impaired CYP2C19 function due to known genetic variation or due to drugs that inhibit CYP2C19 activity. (See WARNINGS and PRECAUTIONS: Drug Interactions.*)

As part of the worldwide postmarketing 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.*)

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.*)

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.*)

*Please See the Full PLAVIX Prescribing Information

PLAVIX Indications

PLAVIX® (clopidigrel bisulfate) is indicated for the reduction of atherothrombotic events as follows:

–
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.

–
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.

–
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.