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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: July 1, 2016
Last verified: July 2016
Results First Received: October 18, 2013  
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
Condition: Myocardial Infarction
Interventions: Drug: Eplerenone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1012 subjects were enrolled for participation in this study. A total of 505 subjects were randomized to treatment with eplerenone and 505 subjects were randomized to the placebo group; a total of 422 and 424 subjects in the eplerenone and placebo groups, respectively, completed the study.

Reporting Groups
  Description
Eplerenone Plus Standard of Care Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
Placebo Plus Standard of Care Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.

Participant Flow:   Overall Study
    Eplerenone Plus Standard of Care     Placebo Plus Standard of Care  
STARTED     506     506  
Treated     505     505  
COMPLETED     422     424  
NOT COMPLETED     84     82  
Adverse Event                 10                 11  
Death                 2                 3  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 16                 14  
Withdrawal by Subject                 48                 48  
Protocol Violation                 2                 1  
Did Not Meet Entrance Criteria                 1                 0  
Study terminated by sponsor                 0                 1  
Reason not defined                 5                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Eplerenone Plus Standard of Care Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
Placebo Plus Standard of Care Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Total Total of all reporting groups

Baseline Measures
    Eplerenone Plus Standard of Care     Placebo Plus Standard of Care     Total  
Number of Participants  
[units: participants]
  506     506     1012  
Age  
[units: Years]
Mean (Standard Deviation)
  58.5  (10.8)     57.8  (11.0)     58.2  (10.9)  
Gender  
[units: Participants]
     
Female     86     103     189  
Male     420     403     823  



  Outcome Measures
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1.  Primary:   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: 0-24 months ]

2.  Secondary:   Cardiovascular Mortality   [ Time Frame: 0-24 months ]

3.  Secondary:   Diagnosis of Heart Failure   [ Time Frame: 0-24 months ]

4.  Secondary:   First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.   [ Time Frame: 0-24 months ]

5.  Secondary:   First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).   [ Time Frame: 0-24 months ]

6.  Secondary:   Brain (B-type) Natriuretic Peptide (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: 0-24 months ]

7.  Secondary:   Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).   [ Time Frame: 0-24 months ]

8.  Secondary:   Second or Subsequent Non-fatal Myocardial Infarction (MI).   [ Time Frame: 0-24 months ]

9.  Secondary:   Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.   [ Time Frame: 6 months ]

10.  Secondary:   Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).   [ Time Frame: 0-24 months ]

11.  Secondary:   Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.   [ Time Frame: 6 months ]

12.  Secondary:   Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.   [ Time Frame: 6 months ]

13.  Secondary:   Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.   [ Time Frame: 6 months ]

14.  Secondary:   Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01176968     History of Changes
Other Study ID Numbers: A6141116
2010-019844-38 ( EudraCT Number )
REMINDER ( Other Identifier: Alias Study Number )
Study First Received: August 4, 2010
Results First Received: October 18, 2013
Last Updated: July 1, 2016
Health Authority: Canada: Health Canada