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Research

Photo for OASIS 3 - CREATE - ECLA

OASIS 3 - CREATE - ECLA

Official Title

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

Status

Completed

Overview

To evaluate the effects of high-dose glucose, insulin, and potassium (GIK) on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation. GIK infusion in patients with STEMI had no significant impact on mortality and other major cardiac events.

Study Design

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

Primary Endpoint

The primary outcome measure was mortality from any cause at 30 days after randomization. Secondary outcome measures included the composite of death or nonfatal cardiac arrest, death or cardiogenic shock, death or reinfarction, and each of these individually.

Number of Patients

20201

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.
  • Mehta SR, Yusuf S, Díaz R, Zhu J, Pais P, Xavier D, Paolasso E, Ahmed R, Xie C, Kazmi K, Tai J, Orlandini A, Pogue J, Liu L; CREATE-ECLA Trial Group Investigators. Effect of glucose-insulin-potassium infusion on mortality in patients with acute ST-segment elevation myocardial infarction: the CREATE-ECLA randomized controlled trial. JAMA. 2005 Jan 26;293(4):437-46.