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Research

Photo for OASIS 3 - CREATE

OASIS 3 - CREATE

Official Title

The Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation

Status

Completed

Overview

To evaluate the effects of reviparin, a low-molecular-weight heparin, on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation. The trial found that in patients with acute ST-segment elevation reviparin reduces mortality and reinfarction, without a substantive increase in overall stroke rates. There was a small absolute excess of life-threatening bleeding but the benefits outweigh the risks.

Study Design

Randomized, controlled trial with partial 2×2 factorial design.

Primary Endpoint

The first coprimary outcome was a composite of death, reinfarction, or stroke at 7 days, while the second coprimary outcome was the first outcome with the addition of ischemia with electrocardiogram changes, also at 7 days. Secondary outcomes included the components of these coprimary outcomes, any ischemia at 7 days, and 30-day outcomes, which included the same composites. The major safety outcme was major bleeding. All efficacy and safety outcomes were adjudicated.

Number of Patients

15570

Number of Sites

89

Number of Countries

2

Study Period

2000–2004

Principal Investigator

Salim Yusuf, Shamir Mehta

Program Manager

Not Applicable

Research Coordinator

Susan Chrolavicius

Key Publications

  • Yusuf S, Mehta SR, Xie C, Ahmed RJ, Xavier D, Pais P, Zhu J, Liu L; CREATE Trial Group Investigators. Effects of reviparin, a low-molecular-weight heparin, on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation. JAMA 2005; 293(4): 427-35.