Phase 4
Completed N=1,012
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
Source: ClinicalTrials.gov NCT01176968 ↗Enrolled (actual)
1,012
Serious AEs
19.9%
Results posted
Aug 2016
Primary outcomePrimary: 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 — 92; 149 Events — p=< 0.0001
◆ Published Evidence
Highly cited
183citations · ~15 / year
Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study.
Summary
Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.
Linked Publications
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Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
92; 149 | < 0.0001 sig |
| SECONDARY Cardiovascular Mortality |
2; 2 | 0.6406 |
| SECONDARY Diagnosis of Heart Failure |
7; 11 | 0.5338 |
| SECONDARY First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation. |
0; 0 | — |
| SECONDARY First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization). |
20; 19 | 0.8042 |
| 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). |
81; 131 | 0.0003 sig |
| SECONDARY Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT). |
3; 3 | 0.9353 |
| SECONDARY Second or Subsequent Non-fatal Myocardial Infarction (MI). |
10; 6 | 0.3757 |
| SECONDARY Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization. |
93.31; 94.62 | 0.1744 |
| SECONDARY Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted). |
3.92; 3.90; 3.91; 3.87 | 0.7123 |
| SECONDARY Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization. |
0.355; 0.210; 379.0; 366.0 | < 0.0001 sig |
| SECONDARY Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization. |
4.20; 4.30; 11.20; 10.60; 30.0; 32.0 | 0.0005 sig |
| SECONDARY Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization. |
3.70; 3.70 | 0.0944 |
| SECONDARY Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization. |
1.845; 1.755 | < 0.0001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01176968) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.