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

Viatris

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Eplerenone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176968

A6141116

REMINDER (Other Identifier)

2010-019844-38 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 1,012 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,012 participants in 2 patient groups, including a placebo group

Eplerenone plus standard of care

Experimental group

Treatment:

Drug: Eplerenone

Placebo plus standard of care

Placebo Comparator group

Description:

Matching placebo for eplerenone 25mg film coated tablets.

Treatment:

Drug: Placebo