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
  Purpose

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


Condition Intervention Phase
Myocardial Infarction
Drug: Eplerenone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1013
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplerenone plus standard of care 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
Placebo Comparator: Placebo plus standard of care
Matching placebo for eplerenone 25mg film coated tablets.
Drug: Placebo
Matching placebo tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176968

  Show 66 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01176968     History of Changes
Other Study ID Numbers: A6141116
Study First Received: August 4, 2010
Last Updated: March 14, 2013
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
Eplerenone
myocardial infarction
mortality
morbidity

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014