An International, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of Fondaparinux versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-Segment Elevation MI Acute Coronary Syndromes
To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refractory ischemia up to day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy. Fondaparinux was similar to enoxaparin in reducing the risk of ischemic events but it substantially reduced bleeding an improved long-term mortality and morbidity. The findings the OASIS 5 and 6 trial sled to widespread use, guideline modifications and regulatory approvals for fondaparinux in many countries.
Randomized, double-blind, active control, parallel group design, safety/efficacy study.
Primary endpoint: first occurrence of death, myocardial infarction or refractory ischemia up to day 9; Secondary Endpoints: composite of death or MI and composite of death, MI, or refractory ischemia up to days 30, 90, and 180. Major safety outcome: major bleeding up to day 9 after randomization. The efficacy-safety outcome is the first occurrence of death, MI, refractory ischemia, or major bleeding at day 9. All endpoints were adjudicated.
Salim Yusuf, Shamir Mehta Project Officer