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
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
The statistical significance favoring PLAVIX over aspirin was marginal (P=0.045). However, because aspirin is itself effective in reducing CV events in patients with recent MI or stroke, the effect of PLAVIX is substantial.3
Learn more about the CAPRIE Trial
Learn more about PLAVIX Safety and side effects
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
Learn more about the CURE Trial
Learn more about PLAVIX Safety and side effects
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.
Learn more about the COMMIT Trial
Learn more about PLAVIX Safety and side effects
- 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 (n=262) vs. 21.7% for placebo + aspirin (n=377)
- 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.
Learn more about the CLARITY Trial
Learn more about PLAVIX Safety and side effects
The effectiveness of PLAVIX is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 (See WARNINGS and PRECAUTIONS: Drug Interactions.*). PLAVIX at recommended doses forms less of that metabolite and has a smaller effect on platelet function in patients who are CYP2C19 poor metabolizers. Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with PLAVIX at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy (See Clinical Pharmacology.*). Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers (See Dosage and Administration.*).
Important Safety Information
PLAVIX is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PLAVIX is contraindicated in patients with hypersensitivity (eg, anaphylaxis) to clopidogrel or any component of the product. (See Adverse Reactions.*)
Avoid concomitant use of PLAVIX and drugs that inhibit CYP2C19 activity. Co-administration of PLAVIX with omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of PLAVIX if given concomitantly or if given 12 hours apart. (See Drug Interactions.*)
Thienopyridines, including PLAVIX, increase the risk of bleeding. If a patient is to undergo surgery and an antiplatelet effect is not desired, discontinue PLAVIX 5 days prior to surgery.
Avoid lapses in therapy, and if PLAVIX must be temporarily discontinued, restart as soon as possible. Premature discontinuation of PLAVIX may increase the risk of cardiovascular events.
In patients with recent TIA or stroke who are at high risk for recurrent ischemic events, the combination of aspirin and PLAVIX has not been shown to be more effective than PLAVIX alone, but the combination has been shown to increase major bleeding.
TTP, sometimes fatal, has been reported following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that requires urgent treatment including plasmapheresis (plasma exchange).
Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction.
Co-administering warfarin with PLAVIX increases the risk of bleeding.
Co-administration of PLAVIX and NSAIDs increases the risk of gastrointestinal bleeding.
Nursing mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother.
*Please See the Full PLAVIX Prescribing Information, Including BOXED WARNING
Indications
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization, PLAVIX has been shown to decrease the rate of a combined end point of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), PLAVIX has been shown to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.
The optimal duration of PLAVIX therapy in ACS is unknown.
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, PLAVIX has been shown 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.