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Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

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NCT01176968

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Subjects with eGFR ?30ml/min (based on admission serum creatinine and the MDRD
formula) or serum creatinine ?220µmol/L.

NCT01176968
Pfizer
Completed
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

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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 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
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.
 
Completed
1012
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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
2010-019844-38 ( EudraCT Number )
REMINDER ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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