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Research

Photo for OASIS 5 - MICHELANGELO

OASIS 5 - MICHELANGELO

Official Title

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

Status

Completed

Overview

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.

Study Design

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

Primary Endpoint

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.

Number of Patients

20078

Number of Sites

576

Number of Countries

41

Study Period

2002–2008

Principal Investigator

Salim Yusuf, Shamir Mehta Project Officer

Program Manager

Susan Chrolavicius

Research Coordinator

Not Applicable

Key Publications

  • Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue, J, Granger CB, Budaj A, Peters RJG, Bassand JP, Wallentin L, Joyner C, Fox KAA for the Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006; 354(14):1464-76. Epub 2006 Mar 14
  • Mehta SR, Boden WE, Eikelboom JW, Flather M, Steg PG, Avezum A, Afzal R, Piegas LS, Faxon DP, Widimsky P, Budaj A, Chrolavicius S, Rupprecht HJ, Jolly S, Granger CB, Fox KA, Bassand JP, Yusuf S; OASIS 5 and 6 Investigators. Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non-ST-segment elevation acute coronary syndromes: an individual patient-level combined analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials. Circulation. 2008;118(20):2038-46