Aldosterone Lethal Effects Blocked in AMI Treated With or Without Reperfusion to Improve Outcome and Survival at Six Months Follow-up: THE ALBATROSS TRIAL

NCT01059136 Phase 3 COMPLETED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	COMPLETED
Enrolment	1603
Start date	2010-02
Completion	2014-08

Conditions

• Myocardial Infarction

Interventions

• Spironolactone

Primary outcomes

• The 6 month rate of the composite of death, resuscitated cardiac arrest, potentially lethal ventricular arrhythmia, indication for implantable cardioversion device, occurrence or aggravation of heart failure. — 6 months

Countries

France