CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,603 enrolled
Drug / intervention
Spironolactonedrug
Likely dose
Spironolactone 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01059136
NCT01059136Phase 3Completed

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

Assistance Publique - Hôpitaux de Paris·interventional·Posted Jan 29, 2010·Updated Jun 11, 2015

In Brief

A Phase 3 clinical trial evaluating Spironolactone for Myocardial Infarction. Completed, enrolled 1,603 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2010
Enrollment StartFeb 1, 2010
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.4 years ago

Interventions

Spironolactonedrug

Unique 200mg IV dose of Potassium Canrenoate followed by 25 mg daily oral dose of Spironolactone for 6 months