STUDY DESIGN

CURE is a international, multi-centre, randomized, parallel group, double blind, clinical trial of clopidogrel versus placebo in patients with unstable angina or myocardial infarction without ST segment elevation (acute coronary syndrome [ACS]) who are receiving ASA therapy.

The original sample size of 9,000 patients was increased to 12,500 in June, 1999 due to a lower than expected event rate.

Patients were randomized through an automated central randomization service from the Canadian Cardiovascular Collaboration (CCC) Project Office.

Patients were treated in the acute phase with a 300mg loading dose of study drug followed by 75mg daily for the duration of follow-up which varied between a minimum of 3 months to a maximum of 12 months.