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Aldosterone Blockade Early After Acute Myocardial Infarction (ALBATROSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059136
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE January 28, 2010
First Posted Date  ICMJE January 29, 2010
Last Update Posted Date June 11, 2015
Study Start Date  ICMJE February 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
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. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
  • Any of the criteria of the primary endpoint [ Time Frame: 6 months ]
  • primary endpoint+ myocardial infarction+stroke cardiovascular death [ Time Frame: 6 months ]
  • death + resuscitated cardiac arrest [ Time Frame: 6 months ]
  • Death+resuscitated cardiac arrest+ventricular arrhythmia+indication for implantable defibrillator device [ Time Frame: 6 months ]
  • death+heart failure [ Time Frame: 6 months ]
  • Acute renal failure [ Time Frame: 6 months ]
  • primary endpoint [ Time Frame: hospital discharge and 30 days ]
  • rate of hyperkaliemia (> 5.5 mmol.l-1) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aldosterone Blockade Early After Acute Myocardial Infarction
Official Title  ICMJE Aldosterone Lethal Effects Blocked in AMI Treated With or Without Reperfusion to Improve Outcome and Survival at Six Months Follow-up: THE ALBATROSS TRIAL
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.

Detailed Description

Rational :The blockade of the renin-angiotensin-aldosterone (RAA) pathway by angiotensin conversion enzyme inhibitors (ACEI) is one corner stone in the management of heart failure as well as the management of ischemic heart disease, especially after acute myocardial infarctionHigh plasma aldosterone levels have been associated with both direct and indirect toxic effects on myocardium. ACEIs are associated with partial and temporary reduction of plasma aldosterone levels.The RALES randomized controlled trial has shown a reduction of mortality associated with the use of the selective aldosterone receptor blocker spironolactone, on top of standard therapy including ACEIs in the setting of NYHA 3-4 chronic heart failure. The EPHESUS randomized controlled trial has shown a reduction of mortality associated with the use of another selective aldosterone receptor blocker Eplerenone, initiated 3 to 14 days after acute myocardial infarction complicated by clinical heart failure and left ventricular ejection fraction < 40%.Both previous studies have also reported a rapid reduction of global and arrhythmia-related mortality, within 30 days after the initiation of the medication.Such benefit has been reported after delayed initiation of aldosterone blocked, while aldosterone is at its highest level at presentation after acute myocardial infarction, with a rapid decrease within days after admission. Furthermore high aldosterone levels on admission are associated with adverse outcome independent of heart failure.

The ALBATROSS trial :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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Drug: Spironolactone
Unique 200mg IV dose of Potassium Canrenoate followed by 25 mg daily oral dose of Spironolactone for 6 months
Study Arms  ICMJE
  • Experimental: 1:Spironolactone
    Aldosterone blockade on top of standard therapy
    Intervention: Drug: Spironolactone
  • No Intervention: 2:Standard therapy
    Standard therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)
1603
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2010)
1600
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01059136
Other Study ID Numbers  ICMJE P071216
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Saliha DJANE, Department of clinical research and development
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Farzin BEYGUI, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP