Collaborative Organization for RheothRx Evaluation
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.
Open label, placebo–controlled dose-finding trial
Primary efficacy endpoint: composite of death, reinfarction or cardiogenic shock; Secondary efficacy endpoints: disabling stroke, LV function. Key endpoints were adjudicated.