Clinical Trials

COMMIT Trial


The COMMIT Trial (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) was a randomized, double-blind, placebo-controlled trial with a 2x2 factorial design. In all, 45,853 patients from 1,250 centers in China presenting within 24 hours of the onset of symptoms of suspected MI with supporting ECG abnormalities were randomized to receive PLAVIX 75 mg once daily or placebo in combination with aspirin 162 mg once daily for 28 days or hospital discharge.


COMMIT Trial Results

COMMIT–45,852 STEMI Patients in the
Acute Care Setting1

Relative risk reduction of 7% for death before discharge, with PLAVIX + Aspirin rate of 7.5%, and Placebo + Aspirin 8.1% up to 28 days since randomization.

Lower all-cause mortality for ACS patient with STEMI (onset ≤24 hours) up to 28 days1,6

  • The primary outcome of death occurred in 7.5% of patients in the PLAVIX + aspirin group and 8.1% in the placebo + aspirin group during the scheduled treatment period.
  • 7% RELATIVE RISK REDUCTION for all-cause mortality (P=0.029).

Safety

In the COMMIT Trial of 45,852 STEMI Patients, the overall rate of non-cerebral major bleeding or cerebral bleeding was low and similar in both groups1


PLAVIX + aspirin in STEMI % Incidence
COMMIT–until hospital discharge or
up to 28 days1		 PLAVIX + aspirin
n=22,961		 Placebo + aspirin
n=22,891		 P-value
Major bleeding 0.6 0.5 0.59
Major non-cerebral bleeding 0.4 0.3 0.48
Fatal non-cerebral bleeding 0.2 0.2 0.90
Hemorrhagic stroke 0.2 0.2 0.91
Fatal hemorrhagic stroke 0.2 0.2 0.81
Other non-cerebral bleeding (nonmajor) 3.6 3.1 0.005
Any non-cerebral bleeding 3.9 3.4 0.004

Major bleeding rates were cerebral bleeds or non-cerebral bleeds thought to have caused death or that required transfusion.


In the COMMIT Trial, 11,934 patients were ≥70 years old6

The relative rate of major non-cerebral or cerebral bleeding was independent of age (event rates by age for PLAVIX and aspirin vs. placebo and aspirin: <60=0.3% vs. 0.4%; ≥60 to <70=0.7% vs. 0.6%; ≥70=0.8% vs. 0.7%

View the COMMIT Trial — Journal Abstract

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.1

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%).1,3

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

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.