Clinical Trials

CAPRIE Trial


PLAVIX vs. Aspirin:
Proven risk reduction head-to-head vs. aspirin 325 mg1

In recent myocardial infarction (MI), recent ischemic stroke, or established PAD patients, PLAVIX demonstrated greater risk reduction of MI, ischemic stroke, and vascular death

Prior studies have demonstrated that aspirin vs. placebo resulted in a 23% relative risk reduction2

CAPRIE*–19,185 recent MI, recent ischemic stroke, or
established PAD patients

CAPRIE Trial cumulative event rates in recent MI or ischemic stroke, or established PAD patients showed 8.7% relative risk reduction in PLAVIX (9.8%) vs. Aspirin (10.6%) at 36 months of follow-up.

* The CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) Trial 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).3

Benefits of PLAVIX were seen early and maintained up to 3 years3

  • A randomized clinical trial to assess the potential benefit of PLAVIX 75 mg vs. aspirin 325 mg/day in reducing the relative risk of a combined end point of MI, ischemic stroke, or vascular death
    • 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 recent stroke. Thus, the difference between PLAVIX and placebo, although not measured directly, is substantial.3

Similar Bleeding and Adverse Event Rates with PLAVIX 75mg to Aspirin 325 mg

PLAVIX in recent MI, recent ischemic
stroke, or established PAD		 % Incidence
CAPRIE–up to 3 years1,3 PLAVIX 75 mg
n=9,599		 Aspirin 325 mg
n=9,586
Intracranial hemorrhage 0.4 0.5
GI bleeding 2.0 2.7
Hospitalization due to GI hemorrhage 0.7 1.1

In patients with recent transient ischemic attack (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.


PLAVIX vs. Aspirin Treatment Tolerability1

Selected adverse events occurring in ≥2.5% of PLAVIX patients with discontinuation rates ≥0.2%

PLAVIX in recent MI, recent ischemic
stroke, or established PAD		 % Incidence (% Discontinuance)
CAPRIE–up to 3 years PLAVIX 75 mg
n=9,599		 Aspirin 325 mg
n=9,586
Chest pain 8.3 (0.2) 8.3 (0.3)
Headache 7.6 (0.3) 7.2 (0.2)
Dizziness 6.2 (0.2) 6.7 (0.3)
GI system disorders–Any event 27.1 (3.2) 29.8 (4.0)
Abdominal pain 5.6 (0.7) 5.2 (0.6)
Dyspepsia 5.2 (0.6) 6.1 (0.7)
Diarrhea 4.5 (0.4) 3.4 (0.3)
Nausea 3.4 (0.5) 3.8 (0.4)
Purpura/Bruise 5.3 (0.3) 3.7 (0.1)
Epistaxis 2.9 (0.2) 2.5 (0.1)
Skin & appendage disorders–Any event 15.8 (1.5) 13.1 (0.8)
Rash 4.2 (0.5) 3.5 (0.2)
Pruritus 3.3 (0.3) 1.6 (0.1)

Thrombotic thrombocytopenic purpura (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).1

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.

View the CAPRIE Trial — Journal Abstract

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.