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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01176968
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Myocardial Infarction
Interventions Drug: Eplerenone
Drug: Placebo
Enrollment 1012
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description 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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Period Title: Overall Study
Started 506 506
Treated 505 505
Completed 422 424
Not Completed 84 82
Reason Not Completed
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
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care Total
Hide Arm/Group Description 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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets. Total of all reporting groups
Overall Number of Baseline Participants 506 506 1012
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 506 participants 506 participants 1012 participants
58.5  (10.8) 57.8  (11.0) 58.2  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 506 participants 506 participants 1012 participants
Female
86
  17.0%
103
  20.4%
189
  18.7%
Male
420
  83.0%
403
  79.6%
823
  81.3%
1.Primary Outcome
Title 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
Hide Description Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
92 149
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.581
Confidence Interval (2-Sided) 95%
0.446 to 0.756
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Cardiovascular Mortality
Hide Description The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6406
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.562
Confidence Interval (2-Sided) 95%
0.050 to 6.308
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Diagnosis of Heart Failure
Hide Description The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
7 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5338
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.726
Confidence Interval (2-Sided) 95%
0.265 to 1.990
Estimation Comments [Not Specified]
4.Secondary Outcome
Title First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.
Hide Description The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
0 0
5.Secondary Outcome
Title First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).
Hide Description The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
20 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8042
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.083
Confidence Interval (2-Sided) 95%
0.575 to 2.040
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 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).
Hide Description The occurrence of first occurrence of BNP >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for ages <50 years, 50 to 75 years and >75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
81 131
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.598
Confidence Interval (2-Sided) 95%
0.452 to 0.791
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).
Hide Description The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
3 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9353
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.069
Confidence Interval (2-Sided) 95%
0.213 to 5.371
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Second or Subsequent Non-fatal Myocardial Infarction (MI).
Hide Description The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Measure Type: Number
Unit of Measure: Events
10 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3757
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.600
Confidence Interval (2-Sided) 95%
0.566 to 4.525
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.
Hide Description Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 347 343
Mean (Standard Deviation)
Unit of Measure: Milliseconds (msec)
93.31  (15.04) 94.62  (16.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1744
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.45
Confidence Interval (2-Sided) 95%
-3.55 to 0.65
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).
Hide Description LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.
Time Frame 0-24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 506 506
Mean (Standard Deviation)
Unit of Measure: Centimeters (cm)
Month 6 (N = 268, 243) 3.92  (0.654) 3.90  (0.703)
Final Visit (N = 393, 378) 3.91  (0.641) 3.87  (0.658)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7123
Comments ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.10 to 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4105
Comments ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.05 to 0.13
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.
Hide Description Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (carboxyterminal telopeptide of type I collagen [ICTP], procollagen type I N-terminal peptide [PINP], procollagen type III N-terminal peptide [PIIINP], Interleukin-6, aldosterone, cortisol, and Galactin 3) available.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 266 260
Median (Inter-Quartile Range)
Unit of Measure: nmol/L
Aldosterone
0.355
(0.210 to 0.540)
0.210
(0.150 to 0.310)
Serum Cortisol
379.0
(292.0 to 492.0)
366.0
(271.0 to 482.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care
Comments For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus Standard of Care
Comments For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.5552
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Wilcoxon Rank-Sum test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care
Comments For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo Plus Standard of Care
Comments For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3347
Comments [Not Specified]
Method Wilcoxon Rank-Sum test
Comments [Not Specified]
12.Secondary Outcome
Title Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.
Hide Description Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 266 260
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
PIIINP
4.20
(3.50 to 4.90)
4.30
(3.60 to 5.10)
Galectin 3
11.20
(9.20 to 13.50)
10.60
(9.10 to 12.40)
PINP
30.0
(24.0 to 39.0)
32.0
(24.0 to 42.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care
Comments For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus Standard of Care
Comments For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1558
Comments [Not Specified]
Method Wilcoxon-Rank Sum test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care
Comments For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo Plus Standard of Care
Comments For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0293
Comments [Not Specified]
Method Wilcoxon Rank-Sum test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care
Comments For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1723
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo Plus Standard of Care
Comments For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0295
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0865
Comments [Not Specified]
Method Wilcoxon Rank-Sum test
Comments [Not Specified]
13.Secondary Outcome
Title Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.
Hide Description Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 266 260
Median (Inter-Quartile Range)
Unit of Measure: μg/L
3.70
(3.20 to 4.50)
3.70
(3.20 to 4.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care
Comments For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0944
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus Standard of Care
Comments For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0360
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6459
Comments [Not Specified]
Method Wilcoxon Rank-Sum test
Comments [Not Specified]
14.Secondary Outcome
Title Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.
Hide Description Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description:
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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
Overall Number of Participants Analyzed 266 260
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
1.845
(1.235 to 2.955)
1.755
(1.180 to 2.480)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care
Comments For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus Standard of Care
Comments For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eplerenone Plus Standard of Care, Placebo Plus Standard of Care
Comments For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0801
Comments [Not Specified]
Method Wilcoxon Rank-Sum test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Hide Arm/Group Description 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 group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
All-Cause Mortality
Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   100/505 (19.80%)   101/505 (20.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/505 (0.20%)  1/505 (0.20%) 
Leukopenia  1  0/505 (0.00%)  1/505 (0.20%) 
Spontaneous haematoma  1  0/505 (0.00%)  1/505 (0.20%) 
Cardiac disorders     
Acute coronary syndrome  1  2/505 (0.40%)  0/505 (0.00%) 
Acute myocardial infarction  1  5/505 (0.99%)  4/505 (0.79%) 
Angina pectoris  1  12/505 (2.38%)  10/505 (1.98%) 
Angina unstable  1  4/505 (0.79%)  9/505 (1.78%) 
Arrhythmia  1  1/505 (0.20%)  0/505 (0.00%) 
Arteriospasm coronary  1  0/505 (0.00%)  1/505 (0.20%) 
Atrial fibrillation  1  1/505 (0.20%)  0/505 (0.00%) 
Atrial flutter  1  1/505 (0.20%)  0/505 (0.00%) 
Atrioventricular block complete  1  1/505 (0.20%)  0/505 (0.00%) 
Atrioventricular block second degree  1  1/505 (0.20%)  1/505 (0.20%) 
Bradycardia  1  1/505 (0.20%)  1/505 (0.20%) 
Cardiac arrest  1  0/505 (0.00%)  1/505 (0.20%) 
Cardiac asthma  1  0/505 (0.00%)  1/505 (0.20%) 
Cardiac failure  1  3/505 (0.59%)  9/505 (1.78%) 
Cardiac failure acute  1  0/505 (0.00%)  1/505 (0.20%) 
Cardiac failure congestive  1  2/505 (0.40%)  4/505 (0.79%) 
Cardiac perforation  1  0/505 (0.00%)  1/505 (0.20%) 
Cardiogenic shock  1  0/505 (0.00%)  2/505 (0.40%) 
Coronary artery disease  1  1/505 (0.20%)  2/505 (0.40%) 
Intracardiac thrombus  1  0/505 (0.00%)  1/505 (0.20%) 
Coronary artery stenosis  1  1/505 (0.20%)  2/505 (0.40%) 
Left ventricular dysfunction  1  1/505 (0.20%)  1/505 (0.20%) 
Left ventricular failure  1  1/505 (0.20%)  0/505 (0.00%) 
Long QT syndrome  1  0/505 (0.00%)  1/505 (0.20%) 
Myocardial infarction  1  5/505 (0.99%)  2/505 (0.40%) 
Myocardial ischaemia  1  1/505 (0.20%)  1/505 (0.20%) 
Palpitations  1  2/505 (0.40%)  0/505 (0.00%) 
Pericardial disease  1  1/505 (0.20%)  0/505 (0.00%) 
Pericardial effusion  1  0/505 (0.00%)  1/505 (0.20%) 
Pericarditis  1  3/505 (0.59%)  2/505 (0.40%) 
Tachyarrhythmia  1  1/505 (0.20%)  0/505 (0.00%) 
Tachycardia  1  1/505 (0.20%)  0/505 (0.00%) 
Ventricular fibrillation  1  0/505 (0.00%)  3/505 (0.59%) 
Ear and labyrinth disorders     
Tinnitus  1  1/505 (0.20%)  0/505 (0.00%) 
Vertigo  1  2/505 (0.40%)  1/505 (0.20%) 
Vertigo positional  1  0/505 (0.00%)  1/505 (0.20%) 
Eye disorders     
Photophobia  1  1/505 (0.20%)  0/505 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/505 (0.00%)  1/505 (0.20%) 
Abdominal pain upper  1  1/505 (0.20%)  1/505 (0.20%) 
Anal fissure  1  1/505 (0.20%)  0/505 (0.00%) 
Anal haemorrhage  1  1/505 (0.20%)  0/505 (0.00%) 
Constipation  1  1/505 (0.20%)  0/505 (0.00%) 
Dieulafoy's vascular malformation  1  0/505 (0.00%)  1/505 (0.20%) 
Erosive oesophagitis  1  1/505 (0.20%)  0/505 (0.00%) 
Gastric polyps  1  1/505 (0.20%)  0/505 (0.00%) 
Gastritis  1  1/505 (0.20%)  0/505 (0.00%) 
Gastritis erosive  1  1/505 (0.20%)  0/505 (0.00%) 
Gastrointestinal haemorrhage  1  0/505 (0.00%)  1/505 (0.20%) 
Gastrooesophageal reflux disease  1  0/505 (0.00%)  1/505 (0.20%) 
Haematemesis  1  1/505 (0.20%)  0/505 (0.00%) 
Nausea  1  1/505 (0.20%)  0/505 (0.00%) 
Peptic ulcer haemorrhage  1  0/505 (0.00%)  1/505 (0.20%) 
Proctitis ulcerative  1  0/505 (0.00%)  1/505 (0.20%) 
Upper gastrointestinal haemorrhage  1  1/505 (0.20%)  0/505 (0.00%) 
General disorders     
Chest discomfort  1  0/505 (0.00%)  1/505 (0.20%) 
Chest pain  1  4/505 (0.79%)  9/505 (1.78%) 
Death  1  1/505 (0.20%)  0/505 (0.00%) 
Device dislocation  1  0/505 (0.00%)  2/505 (0.40%) 
Non-cardiac chest pain  1  2/505 (0.40%)  2/505 (0.40%) 
Sudden death  1  1/505 (0.20%)  0/505 (0.00%) 
Vessel puncture site haemorrhage  1  0/505 (0.00%)  1/505 (0.20%) 
Hepatobiliary disorders     
Biliary colic  1  1/505 (0.20%)  1/505 (0.20%) 
Infections and infestations     
Bronchitis  1  1/505 (0.20%)  0/505 (0.00%) 
Bronchopneumonia  1  1/505 (0.20%)  0/505 (0.00%) 
Cellulitis  1  1/505 (0.20%)  0/505 (0.00%) 
Cholecystitis infective  1  1/505 (0.20%)  0/505 (0.00%) 
Device related infection  1 [1]  2/505 (0.40%)  0/505 (0.00%) 
Gangrene  1  1/505 (0.20%)  0/505 (0.00%) 
Gastroenteritis  1  1/505 (0.20%)  1/505 (0.20%) 
Peritonitis  1  0/505 (0.00%)  1/505 (0.20%) 
Pneumonia  1  1/505 (0.20%)  2/505 (0.40%) 
Subcutaneous abscess  1  0/505 (0.00%)  1/505 (0.20%) 
Urinary tract infection  1  0/505 (0.00%)  1/505 (0.20%) 
Injury, poisoning and procedural complications     
Arteriovenous graft site haemorrhage  1  0/505 (0.00%)  1/505 (0.20%) 
Coronary artery restenosis  1  0/505 (0.00%)  1/505 (0.20%) 
Overdose  1  1/505 (0.20%)  0/505 (0.00%) 
Post procedural haemorrhage  1  0/505 (0.00%)  1/505 (0.20%) 
Tendon rupture  1  1/505 (0.20%)  0/505 (0.00%) 
Vascular graft occlusion  1  1/505 (0.20%)  0/505 (0.00%) 
Investigations     
Haemoglobin decreased  1  0/505 (0.00%)  1/505 (0.20%) 
Metabolism and nutrition disorders     
Dehydration  1  0/505 (0.00%)  1/505 (0.20%) 
Hyperglycaemia  1  2/505 (0.40%)  0/505 (0.00%) 
Hypovolaemia  1  1/505 (0.20%)  0/505 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/505 (0.20%)  0/505 (0.00%) 
Back pain  1  2/505 (0.40%)  1/505 (0.20%) 
Joint hyperextension  1  0/505 (0.00%)  1/505 (0.20%) 
Musculoskeletal chest pain  1  1/505 (0.20%)  0/505 (0.00%) 
Musculoskeletal pain  1  2/505 (0.40%)  0/505 (0.00%) 
Myalgia  1  1/505 (0.20%)  0/505 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  1/505 (0.20%)  0/505 (0.00%) 
Bladder neoplasm  1  0/505 (0.00%)  1/505 (0.20%) 
Bladder papilloma  1  0/505 (0.00%)  1/505 (0.20%) 
Bronchial carcinoma  1  0/505 (0.00%)  1/505 (0.20%) 
Colon cancer  1  0/505 (0.00%)  1/505 (0.20%) 
Lung squamous cell carcinoma stage unspecified  1 [2]  1/505 (0.20%)  0/505 (0.00%) 
Rectal cancer  1  1/505 (0.20%)  0/505 (0.00%) 
Malignant melanoma  1  1/505 (0.20%)  0/505 (0.00%) 
Nervous system disorders     
Cerebellar infarction  1  1/505 (0.20%)  0/505 (0.00%) 
Cerebral artery thrombosis  1 [3]  0/505 (0.00%)  1/505 (0.20%) 
Cerebral haemorrhage  1  1/505 (0.20%)  0/505 (0.00%) 
Cerebral infarction  1  0/505 (0.00%)  1/505 (0.20%) 
Cerebrovascular accident  1  4/505 (0.79%)  2/505 (0.40%) 
Dizziness  1  2/505 (0.40%)  0/505 (0.00%) 
Dysarthria  1  0/505 (0.00%)  1/505 (0.20%) 
Headache  1  1/505 (0.20%)  0/505 (0.00%) 
Ischaemic stroke  1  1/505 (0.20%)  0/505 (0.00%) 
Lethargy  1  1/505 (0.20%)  0/505 (0.00%) 
Loss of consciousness  1  1/505 (0.20%)  0/505 (0.00%) 
Multiple system atrophy  1  1/505 (0.20%)  0/505 (0.00%) 
Subarachnoid haemorrhage  1  1/505 (0.20%)  1/505 (0.20%) 
Syncope  1  3/505 (0.59%)  4/505 (0.79%) 
Thoracic outlet syndrome  1  1/505 (0.20%)  0/505 (0.00%) 
Transient ischaemic attack  1  0/505 (0.00%)  1/505 (0.20%) 
Psychiatric disorders     
Alcoholism  1  0/505 (0.00%)  1/505 (0.20%) 
Confusional state  1  1/505 (0.20%)  0/505 (0.00%) 
Delirium  1  1/505 (0.20%)  0/505 (0.00%) 
Depression  1  1/505 (0.20%)  0/505 (0.00%) 
Psychiatric decompensation  1  0/505 (0.00%)  1/505 (0.20%) 
Psychotic disorder  1  0/505 (0.00%)  1/505 (0.20%) 
Renal and urinary disorders     
Haematuria  1  1/505 (0.20%)  0/505 (0.00%) 
Renal failure acute  1  0/505 (0.00%)  1/505 (0.20%) 
Renal impairment  1  0/505 (0.00%)  1/505 (0.20%) 
Urinary bladder haemorrhage  1 [4]  0/505 (0.00%)  1/505 (0.20%) 
Reproductive system and breast disorders     
Menorrhagia  1  0/505 (0.00%)  1/505 (0.20%) 
Ovarian cyst  1  0/505 (0.00%)  1/505 (0.20%) 
Prostatitis  1  1/505 (0.20%)  0/505 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1 [5]  1/505 (0.20%)  1/505 (0.20%) 
Epistaxis  1  0/505 (0.00%)  1/505 (0.20%) 
Haemoptysis  1  1/505 (0.20%)  0/505 (0.00%) 
Hyperventilation  1  0/505 (0.00%)  1/505 (0.20%) 
Idiopathic pulmonary fibrosis  1 [6]  1/505 (0.20%)  0/505 (0.00%) 
Pulmonary embolism  1  1/505 (0.20%)  1/505 (0.20%) 
Pulmonary oedema  1  1/505 (0.20%)  0/505 (0.00%) 
Vocal cord polyp  1  0/505 (0.00%)  1/505 (0.20%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/505 (0.20%)  0/505 (0.00%) 
Rash  1  1/505 (0.20%)  0/505 (0.00%) 
Surgical and medical procedures     
Implantable defibrillator insertion  1 [7]  1/505 (0.20%)  1/505 (0.20%) 
Inguinal hernia repair  1 [8]  1/505 (0.20%)  0/505 (0.00%) 
Percutaneous coronary intervention  1 [9]  1/505 (0.20%)  0/505 (0.00%) 
Vascular disorders     
Circulatory collapse  1  0/505 (0.00%)  2/505 (0.40%) 
Hypertension  1  1/505 (0.20%)  0/505 (0.00%) 
Hypotension  1  0/505 (0.00%)  1/505 (0.20%) 
Infarction  1  0/505 (0.00%)  1/505 (0.20%) 
Ischaemia  1  1/505 (0.20%)  1/505 (0.20%) 
Orthostatic hypotension  1  1/505 (0.20%)  0/505 (0.00%) 
Peripheral arterial occlusive disease  1 [10]  3/505 (0.59%)  2/505 (0.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
Device related infection
[2]
Lung squamous cell carcinoma stage unspecified
[3]
Cerebral artery thrombosis
[4]
Urinary bladder haemorrhage
[5]
Chronic obstructive pulmonary disease
[6]
Idiopathic pulmonary fibrosis
[7]
Implantable defibrillator insertion
[8]
Inguinal hernia repair
[9]
Percutaneous coronary intervention
[10]
Peripheral arterial occlusive disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Eplerenone Plus Standard of Care Placebo Plus Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   151/506 (29.84%)   153/506 (30.24%) 
Cardiac disorders     
Angina pectoris  1  16/506 (3.16%)  22/506 (4.35%) 
Bradycardia  1  12/506 (2.37%)  7/506 (1.38%) 
Ventricular tachycardia  1  11/506 (2.17%)  7/506 (1.38%) 
Gastrointestinal disorders     
Abdominal pain upper  1  13/506 (2.57%)  3/506 (0.59%) 
Constipation  1  7/506 (1.38%)  13/506 (2.57%) 
Diarrhoea  1  22/506 (4.35%)  14/506 (2.77%) 
Nausea  1  7/506 (1.38%)  11/506 (2.17%) 
General disorders     
Chest pain  1  23/506 (4.55%)  24/506 (4.74%) 
Fatigue  1  10/506 (1.98%)  20/506 (3.95%) 
Non-cardiac chest pain  1  16/506 (3.16%)  13/506 (2.57%) 
Oedema peripheral  1  8/506 (1.58%)  11/506 (2.17%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  11/506 (2.17%)  6/506 (1.19%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  12/506 (2.37%)  13/506 (2.57%) 
Nervous system disorders     
Dizziness  1  21/506 (4.15%)  19/506 (3.75%) 
Headache  1  8/506 (1.58%)  16/506 (3.16%) 
Psychiatric disorders     
Anxiety  1  11/506 (2.17%)  8/506 (1.58%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  16/506 (3.16%)  17/506 (3.36%) 
Dyspnoea  1  12/506 (2.37%)  17/506 (3.36%) 
Vascular disorders     
Hypertension  1  12/506 (2.37%)  18/506 (3.56%) 
Hypotension  1  21/506 (4.15%)  19/506 (3.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
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 )
First Submitted: August 4, 2010
First Posted: August 6, 2010
Results First Submitted: October 18, 2013
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016