completed

The objective of OASIS 5 MICHELANGELO was 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.

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.

Study Type

Interventional - Drug

Study Design

Randomized double-blind active control parallel group

NO. of Countries

41

NO. of Sites

576

NO. of Participants

20078

Study Period

2003 - 2005

Sponsor

GSK

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