Aldosterone Blockade Early After Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

1. Age ≥ 18 ans

2. Ischemic symptom of ≥ 20 minutes

3. Randomization within 72 hours after symptom onset

4. 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.

5. Patients with health insurance

6. Written informed consent obtained from:

1. - the patient

2. -A member of the family or the person of confidence if the patient is unable to provide informed consent

Exclusion Criteria:

1. Contraindication or known intolerance to study drugs

2. Patients already treated by aldosterone blockers for diseases other than systemic hypertension (e.g. primary hyperaldosteronism)

3. Hyperkaliemia >5.5 mmol/l at the time of randomization

4. Renal function impairment :Plasma creatinin level > 220 µmol/l and/or Creatinin clearance 30 ml/min

5. Severe liver deficiency (Child-Pugh Class 3)

6. Pregnant or breast feeding women, or women desiring pregnancy within 6 months after randomization

7. Patients already included in another biomedical intervention trial

8. Life expectancy < 1 year

9. Cardiac arrest lasting (ECM) >10 minutes prior to randomization

10. Patient unable or unwilling to comply with the treatment or the follow-up visits