drugset / Trial / NCT01059136

Aldosterone Blockade Early After Acute Myocardial Infarction

NCT01059136

Phase 3 Completed 1603 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

Study hypothesis : An early blockade of aldosterone receptors initiated at the first medical contact after acute myocardial infarction may reduce major cardiovascular events within 6 months after the occurrence of the myocardial infarction. Primary efficacy criterion : The 6 month rate of the composite of death, resuscitated cardiac arrest, potentially lethal ventricular arrhythmia, indication for implantation of an implantable cardioversion device, occurrence or aggravation of heart failure. Primary objective: To demonstrate the superiority of aldosterone blockade initiated as soon as possible within 72 hours after the onset of acute myocardial infarction on top of standard therapy, compared to standard therapy alone, with or without reperfusion therapy. Study design : Prospective, multi-centre randomised, open labeled with 2 parallel study arms.

Timeline

Start
2010-02
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Canrenoate Small molecule 200 mg Intravenous
Subject Spironolactone Small molecule 25 mg Oral

Indications