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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Eplerenone
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring Eplerenone, myocardial infarction, mortality, morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Alberta Hospital
  • Walter C Mackenzie Health Sciences Centre (WCM)
  • Diamond Health Care Centre (DHCC)
  • Vancouver General Hospital - Centennial Pavilion
  • Vancouver General Hospital, Vancouver Coastal Health Authority
  • Health Sciences Center, Eastern Health
  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital
  • Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)
  • ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi
  • Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice Hradec Kralove
  • I.Interni klinika-kardiologie FN Olomouc
  • I. Interni klinika - kardiologie FN Olomouc
  • Klinika kardiologie IKEM
  • Nemocnice Na Homolce - kardiologicke oddeleni
  • Chu Rangueil Service de Cardiologie, A - Bat H1
  • Chu du Bocage - Centre de Cardiologie
  • Hopital De La Pitie Salpetriere
  • Service Cardiologie, Centre Hospitalier de Cannes
  • Hôpital Henri Mondor - Pysiologie explorations fonctionnelles
  • Hôpital Henri Mondor
  • Centre de Cardiologie d'Evecquemont
  • Service Cardiologie Hopital Robert Boulin
  • Cardiologie Interventionnelle
  • Universitaets-Herzzentrum Freiburg Bad Krozingen
  • Charite - Universitaetsmedizin Berlin
  • Universitätsklinikum Bonn
  • Klinikum Links der Weser gGmbH
  • Sankt Johannes Hospital Medizinische Klinik I
  • Sankt Johannes Hospital
  • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
  • Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie
  • Universitaeres Herzzentrum Hamburg
  • Medizinische Hochschule Hannover
  • St. Vincenz Krankenhaus
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach
  • General Hospital of Athens "Georgios Gennimatas"
  • General Hospital of Attiki KAT
  • University General Hospital of Patra
  • Budai Irgalmasrendi Korhaz, Kardiologia
  • Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly
  • Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia
  • Zala Megyei Korhaz, Kardiologia
  • Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark
  • St. Antonius Ziekenhuis
  • Katedra i Klinika Kardiologii i Chorob Wewnetrznych
  • Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.
  • Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu
  • Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
  • Narodny ustav srdcovych a cievnych chorob, a.s.
  • Univerzitna nemocnica Martin
  • Kardiocentrum Nitra, s.r.o.
  • Vseobecna nemocnica Rimavska Sobota
  • Hospital Del Sas de Jerez de La Frontera
  • "Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax
  • Hospital del Mar.
  • HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid
  • Hospital Universitario de La Paz
  • Hospital Universitari Son Espases
  • Hospital General Universitario de Valencia
  • Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre
  • Edinburgh Royal Infirmary
  • Clinical Trials Unit Morriston Hospital
  • City Hospital
  • Academic cardiology Unit
  • University Hospitals Coventry and Warwickshire NHS Trust
  • Ninewells Hospital and Medical School
  • The Queens Medical Research Institute- University of Edinburgh
  • University Hospital of Leicester (UHL) NHS Trust
  • Clinical Trials Unit, Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eplerenone plus standard of care

Placebo plus standard of care

Arm Description

Matching placebo for eplerenone 25mg film coated tablets.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Cardiovascular Mortality
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.
Diagnosis of Heart Failure
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.
First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.
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.
First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).
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.
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).
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.
Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).
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.
Second or Subsequent Non-fatal Myocardial Infarction (MI).
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.
Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.
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.
Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).
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.
Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.
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.
Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.
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.
Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.
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.
Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.
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.

Full Information

First Posted
August 4, 2010
Last Updated
December 19, 2020
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01176968
Brief Title
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
Acronym
REMINDER
Official Title
A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Eplerenone, myocardial infarction, mortality, morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1012 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone plus standard of care
Arm Type
Experimental
Arm Title
Placebo plus standard of care
Arm Type
Placebo Comparator
Arm Description
Matching placebo for eplerenone 25mg film coated tablets.
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Inspra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
Title
Cardiovascular Mortality
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
Title
Diagnosis of Heart Failure
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
Title
First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.
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
Title
First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).
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
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).
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
Title
Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).
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
Title
Second or Subsequent Non-fatal Myocardial Infarction (MI).
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
Title
Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.
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
Title
Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).
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
Title
Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.
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
Title
Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.
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
Title
Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.
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
Title
Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Walter C Mackenzie Health Sciences Centre (WCM)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Diamond Health Care Centre (DHCC)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver General Hospital - Centennial Pavilion
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver General Hospital, Vancouver Coastal Health Authority
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Health Sciences Center, Eastern Health
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7P2
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
I.Interni klinika-kardiologie FN Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
I. Interni klinika - kardiologie FN Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Klinika kardiologie IKEM
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Nemocnice Na Homolce - kardiologicke oddeleni
City
Praha 5
ZIP/Postal Code
150 30
Country
Czechia
Facility Name
Chu Rangueil Service de Cardiologie, A - Bat H1
City
Toulouse
State/Province
Cedex 4
ZIP/Postal Code
31403
Country
France
Facility Name
Chu du Bocage - Centre de Cardiologie
City
Dijon
State/Province
Cedex
ZIP/Postal Code
21034
Country
France
Facility Name
Hopital De La Pitie Salpetriere
City
Paris
State/Province
Cedex
ZIP/Postal Code
75013
Country
France
Facility Name
Service Cardiologie, Centre Hospitalier de Cannes
City
Cannes
ZIP/Postal Code
06401
Country
France
Facility Name
Hôpital Henri Mondor - Pysiologie explorations fonctionnelles
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre de Cardiologie d'Evecquemont
City
Evecquemont
ZIP/Postal Code
78740
Country
France
Facility Name
Service Cardiologie Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Cardiologie Interventionnelle
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Universitaets-Herzzentrum Freiburg Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinikum Links der Weser gGmbH
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Sankt Johannes Hospital Medizinische Klinik I
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Sankt Johannes Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
City
Dresden
ZIP/Postal Code
01309
Country
Germany
Facility Name
Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaeres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
St. Vincenz Krankenhaus
City
Limburg
ZIP/Postal Code
65549
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach
City
Munich
ZIP/Postal Code
81737
Country
Germany
Facility Name
General Hospital of Athens "Georgios Gennimatas"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Attiki KAT
City
Athens
ZIP/Postal Code
14561
Country
Greece
Facility Name
University General Hospital of Patra
City
Rio Patra
ZIP/Postal Code
26500
Country
Greece
Facility Name
Budai Irgalmasrendi Korhaz, Kardiologia
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Zala Megyei Korhaz, Kardiologia
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Katedra i Klinika Kardiologii i Chorob Wewnetrznych
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Narodny ustav srdcovych a cievnych chorob, a.s.
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Kardiocentrum Nitra, s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Vseobecna nemocnica Rimavska Sobota
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
Hospital Del Sas de Jerez de La Frontera
City
Jerez de la Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
"Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital del Mar.
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Edinburgh Royal Infirmary
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Clinical Trials Unit Morriston Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
City Hospital
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Academic cardiology Unit
City
Cottingham Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
The Queens Medical Research Institute- University of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4TJ
Country
United Kingdom
Facility Name
University Hospital of Leicester (UHL) NHS Trust
City
Leicester
ZIP/Postal Code
LE3 GQP
Country
United Kingdom
Facility Name
Clinical Trials Unit, Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24780614
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6141116&StudyName=Impact%20Of%20Eplerenone%20On%20Cardiovascular%20Outcomes%20In%20Patients%20Post%20Myocardial%20Infarction
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

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