Aldosterone Blockade Early After Acute Myocardial Infarction

NCT01059136 | Completed Phase 3 DMC

• 1 other identifier: P071216
• Study Type: interventional
• Target: 1,603
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Outcome; Aldosterone; Spironolactone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Any of the criteria of the primary endpoint

  6 months

• primary endpoint+ myocardial infarction+stroke cardiovascular death

  6 months

• death + resuscitated cardiac arrest

  6 months

• Death+resuscitated cardiac arrest+ventricular arrhythmia+indication for implantable defibrillator device

  6 months

• death+heart failure

  6 months

Study Arms (2)

1:Spironolactone

EXPERIMENTAL

Aldosterone blockade on top of standard therapy

Drug: Spironolactone

2:Standard therapy

NO INTERVENTION

Standard therapy

Interventions

Spironolactone DRUG

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

1:Spironolactone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 ans
• Ischemic symptom of ≥ 20 minutes
• Randomization within 72 hours after symptom onset
• Electrocardiogram or biological evidence of myocardial infarction:
• ST segment elevation ≥ 2 mm in ≥ 2 adjacent precordial derivations
• ST segment elevation ≥ 1 mm in ≥ 2 adjacent peripheral derivations
• New left bundle branch block
• New significant Q wave in ≥ 2 adjacent peripheral derivations
• Troponin levels ≥3 times upper local limit of normal values and Thrombolysis In Myocardial Infarction (TIMI) non-ST elevation myocardial infarction risk score ≥ 3.
• Patients with health insurance
• Written informed consent obtained from:
• \- the patient
• A member of the family or the person of confidence if the patient is unable to provide informed consent

You may not qualify if:

• Contraindication or known intolerance to study drugs
• Patients already treated by aldosterone blockers for diseases other than systemic hypertension (e.g. primary hyperaldosteronism)
• Hyperkaliemia \>5.5 mmol/l at the time of randomization
• Renal function impairment :Plasma creatinin level \> 220 µmol/l and/or Creatinin clearance 30 ml/min
• Severe liver deficiency (Child-Pugh Class 3)
• Pregnant or breast feeding women, or women desiring pregnancy within 6 months after randomization
• Patients already included in another biomedical intervention trial
• Life expectancy \< 1 year
• Cardiac arrest lasting (ECM) \>10 minutes prior to randomization
• Patient unable or unwilling to comply with the treatment or the follow-up visits

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital PITIE-SALPETRIERE - Institut de Cardiologie

Paris, 75013, France

Location

Related Publications (3)

• Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

  PMID: 39878152 DERIVED

• Beygui F, Cayla G, Roule V, Roubille F, Delarche N, Silvain J, Van Belle E, Belle L, Galinier M, Motreff P, Cornillet L, Collet JP, Furber A, Goldstein P, Ecollan P, Legallois D, Lebon A, Rousseau H, Machecourt J, Zannad F, Vicaut E, Montalescot G; ALBATROSS Investigators. Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial. J Am Coll Cardiol. 2016 Apr 26;67(16):1917-27. doi: 10.1016/j.jacc.2016.02.033.

  PMID: 27102506 DERIVED

• Beygui F, Vicaut E, Ecollan P, Machecourt J, Van Belle E, Zannad F, Montalescot G. Rationale for an early aldosterone blockade in acute myocardial infarction and design of the ALBATROSS trial. Am Heart J. 2010 Oct;160(4):642-8. doi: 10.1016/j.ahj.2010.06.049.

  PMID: 20934557 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Farzin BEYGUI, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

FR (1)