Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

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NCT01176968

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Study Location
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
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Contact
1-800-718-1021
[email protected]er.com
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myocardial Infarction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
Brief Summary Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.

*   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: July 1, 2016)		1012
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2010)		612
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Canada,   Czechia,   France,   Germany,   Greece,   Hungary,   Netherlands,   Poland,   Slovakia,   Spain,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01176968
Other Study ID Numbers  ICMJE A6141116
2010-019844-38 ( EudraCT Number )
REMINDER ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

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