completed

The objective of OASIS 6 MICHELANGELO was to determine the efficacy and safety of fondaparinux (Arixtra) in preventing death and repeat heart attacks and their complications in ST-segment elevation acute coronary syndromes.

The trial showed that,in patients with STEMI, particularly those not undergoing primary percutaneous coronary intervention, fondaparinux significantly reduces mortality and reinfarction without increasing bleeding and strokes.

Primary outcome:

Composite of death or recurrent myocardial infarction (MI) up to day 30. These outcomes were also assessed at 9 days and at study end (minimum of 3 and maximum of 6 months).

The main safety outcome was severe bleeding and the balance of benefits and risks was assessed using the composite outcome of death, reinfarction, and severe bleeding at each of the above time points.

Study Type

Interventional - Drug

Study Design

Randomized double-blind active control parallel group

NO. of Countries

41

NO. of Sites

447

NO. of Participants

12092

Study Period

2003 - 2006

Sponsor

GSK

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