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Research

Photo for CORE

CORE

Official Title

Collaborative Organization for RheothRx Evaluation

Status

Completed

Overview

To evaluate the effects of RheothRx (poloxame188) in patient’s acute myocardial infarction. The trial demonstrated that RheothRx had no effect on mortality, reinfarction, cardiogenic shock and an advers effect on renal function, LV ejection fraction and heart failure (especially at higher doses). Based on results of this trial further development of the study drug was discontinued. The early rapid provision of clear results resulted in clear decisions, so that a larger phase III trial was not needed.

Study Design

Open label, placebo–controlled dose-finding trial

Primary Endpoint

Primary efficacy endpoint: composite of death, reinfarction or cardiogenic shock; Secondary efficacy endpoints: disabling stroke, LV function. Key endpoints were adjudicated.

Number of Patients

2938

Number of Sites

200

Number of Countries

19

Study Period

1995–1997

Principal Investigator

Salim Yusuf

Program Manager

Not Applicable

Research Coordinator

Not Applicable

Key Publications

  • Collaborative Organization for RheothRx Evaluation (CORE) Investigators. Effects of RheothRx on mortality, morbidity, left ventricular function and infarct size in patients with acute myocardial infarction. Circulation 1997;96:192-201.