GLOBAL HEALTH | GLOBAL PARTNERSHIPS | GLOBAL IMPACT

Research

Photo for OASIS 6 - MICHELANGELO

OASIS 6 - MICHELANGELO

Official Title

FOndaparinux in ST Elevation Myocardial Infarction. Safety and Efficacy Trial Evaluating Fondaparinux Use in a Broad Range of Patients With ST Segment Elevation Acute MI

Status

Completed

Overview

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. These findings in conjunction with the results of the OASIS –5 trial led to widespread use of fondaparinux in ACs.

Study Design

Randomized, double-blind, active control, parallel group design, safety/efficacy study.

Primary Endpoint

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.

Number of Patients

12092

Number of Sites

447

Number of Countries

41

Study Period

2003–2007

Principal Investigator

Salim Yusuf, Shamir Mehta Project Officer

Program Manager

Susan Chrolavicius

Research Coordinator

Brandi Meeks, Joanne Willcox, Craig Horsman

Key Publications

  • Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA; OASIS-6 Trial Group. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. JAMA. 2006;295(13):1519-30. Epub 2006 Mar 14