Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction (REMINDER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01176968
First received: August 4, 2010
Last updated: March 14, 2013
Last verified: March 2013

August 4, 2010
March 14, 2013
September 2010
October 2012   (final data collection date for primary outcome measure)
Time to first event of cardiovascular mortality,re-hospitalization or extended initial hospital stay due to diagnosis of heart failure,sustained ventricular tachycardia or fibrillation,ejection fraction ≤40% or BNP above age adjusted cut off [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
Time to first event of cardiovascular mortality, re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation. [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01176968 on ClinicalTrials.gov Archive Site
  • Time to cardiovascular mortality [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to diagnosis of heart failure [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to first and each subsequent episode (after an event free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to first recorded ejection fraction of ≤ 40% (recorded 1 month or later post-randomization). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to BNP >200 pg/ml or NT-proBNP >450, >900 or >1800 pg/ml for ages <50 years, 50-75 years and >75 years, respectively (recorded 1 month or later post-randomization). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to decision to provide an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to second or subsequent non-fatal myocardial infarction. [ Time Frame: 0-`23 months ] [ Designated as safety issue: No ]
  • QRS duration at 6 months post-randomization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Left atrial diameter (recorded on each occasion an echocardiogram is conducted). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Change in serum levels of biomarkers at 6 months post-randomization. Blood samples for biomarkers will be stored and analyzed post completion of the study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to cardiovascular mortality [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
  • Time to diagnosis of heart failure [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
  • Time to first and each subsequent episode (after an event free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
  • Time to first recorded ejection fraction of ≤ 40% (recorded 1 month or later post-randomization). [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
  • Time to BNP >200 pg/ml or NT-proBNP >450, >900 or >1800 pg/ml for ages <50 years, 50-75 years and >75 years, respectively (recorded 1 month or later post-randomization). [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
  • Time to decision to provide an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT). [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
  • Time to second or subsequent non-fatal myocardial infarction. [ Time Frame: 0-`18 months ] [ Designated as safety issue: No ]
  • QRS duration at 6 months post-randomization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Left atrial diameter (recorded on each occasion an echocardiogram is conducted). [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
  • Change in serum levels of biomarkers at 6 months post-randomization. Blood samples for biomarkers will be stored and analyzed post completion of the study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
A Double-Blind, Randomized, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction

Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Myocardial Infarction
  • Drug: Eplerenone
    Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.
    Other Name: Inspra
  • Drug: Placebo
    Matching placebo tablets
  • Experimental: Eplerenone plus standard of care
    Intervention: Drug: Eplerenone
  • Placebo Comparator: Placebo plus standard of care
    Matching placebo for eplerenone 25mg film coated tablets.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1013
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.

Exclusion Criteria:

  • Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.
  • Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.
  • The subject has uncontrolled hypotension (SBP<90mmHg).
  • Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Netherlands,   Poland,   Slovakia,   Spain,   United Kingdom
 
NCT01176968
A6141116
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

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