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

Outcome

Missed primary endpoint

paper The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). PMID 27102506 ↗

paper The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. PMID 27102506 ↗

Drugs

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

Indications