Clinical Trials

CLARITY Trial


The CLARITY Trial (CLopidogrel as Adjunctive ReperfusIon TherapY) was a randomized, double-blind, placebo-controlled trial of 3,491 patients (5% US) from 319 centers in 23 countries presenting within 12 hours of the onset of ST-segment elevation acute myocardial infarction (MI) who were scheduled to receive thrombolytic therapy. Patients were randomized to receive a PLAVIX 300 mg loading dose, followed by PLAVIX 75 mg once daily or placebo up to the day of angiography. Those not receiving angiography received treatment up to day 8 or discharge, whichever came first. All patients received aspirin (150 mg-325 mg on the first day and 75 mg-162 mg/day thereafter). Patients were followed 30 days.


CLARITY Trial Results

CLARITY–3,491 ACS Patients with STEMI1,7

ACS Patients with STEMI over 30 days showed 36% odds reduction in the primary endpoint, with PLAVIX + Aspirin at 15% and Placebo + Aspirin at 21.7%.

Reduced odds of occlusion in the infarct-related artery on predischarge angiography; or death or recurrent MI1,7

  • Event rate: 15% for PLAVIX + aspirin vs. 21.7% for placebo + aspirin
  • 36% ODDS REDUCTION (P<0.001)
  • Most of the events related to the surrogate end point of vessel patency [Odds Reduction: 41%; PLAVIX + aspirin (11.7%; 192/1,640) vs. placebo + aspirin (18.4%; 301/1,634); 95% CI: 0.48 to 0.72]

Safety

In the CLARITY trial of 3,491 STEMI patients, the incidence of fatal bleeding and intracranial hemorrhage was low and similar in both groups1,7


PLAVIX + aspirin in STEMI % Incidence
CLARITY–until angiography,
discharge, or day 81*		 PLAVIX + aspirin
n=1,733		 Placebo + aspirin
n=1,719
TIMI major bleeding through day
after angiography1		 1.3 1.1
Intracranial hemorrhage 0.5 0.7
Fatal bleeding 0.8 0.6

*Patients were scheduled to undergo angiography 48 to 192 hours after the start of study medication. For patients who did not undergo angiography, the primary end point was death or recurrent MI by day 8 or by hospital discharge if prior to day 8

†Major bleeding was defined as intracranial bleeding or bleeding associated with a fall in hemoglobin >5 g/dL.

  • Major bleeding rates were consistent across subgroups and type of fibrinolytic or heparin therapy1,7

View the CLARITY 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.