Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176968
• Other study ID #: A6141116
• Secondary ID: 2010-019844-38RE
• Status: Completed
• Phase: Phase 4
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Eplerenone
Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.
• Placebo
Matching placebo tablets

Locations

Country	Name	City	State
Canada	Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)	Chicoutimi	Quebec
Canada	ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi	Chicoutimi	Quebec
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Walter C Mackenzie Health Sciences Centre (WCM)	Edmonton	Alberta
Canada	Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont	Sherbrooke	Quebec
Canada	Health Sciences Center, Eastern Health	St. John's	Newfoundland and Labrador
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Diamond Health Care Centre (DHCC)	Vancouver	British Columbia
Canada	Vancouver General Hospital - Centennial Pavilion	Vancouver	British Columbia
Canada	Vancouver General Hospital, Vancouver Coastal Health Authority	Vancouver	British Columbia
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	I. Interni klinika - kardiologie FN Olomouc	Olomouc
Czechia	I.Interni klinika-kardiologie FN Olomouc	Olomouc
Czechia	Klinika kardiologie IKEM	Praha 4
Czechia	Nemocnice Na Homolce - kardiologicke oddeleni	Praha 5
France	Service Cardiologie, Centre Hospitalier de Cannes	Cannes
France	Hôpital Henri Mondor	Creteil
France	Hôpital Henri Mondor - Pysiologie explorations fonctionnelles	Creteil
France	Chu du Bocage - Centre de Cardiologie	Dijon	Cedex
France	Centre de Cardiologie d'Evecquemont	Evecquemont
France	Service Cardiologie Hopital Robert Boulin	Libourne
France	Hopital De La Pitie Salpetriere	Paris	Cedex
France	Cardiologie Interventionnelle	Pessac Cedex
France	Chu Rangueil Service de Cardiologie, A - Bat H1	Toulouse	Cedex 4
Germany	Universitaets-Herzzentrum Freiburg Bad Krozingen	Bad Krozingen
Germany	Charite - Universitaetsmedizin Berlin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Klinikum Links der Weser gGmbH	Bremen
Germany	Sankt Johannes Hospital	Dortmund
Germany	Sankt Johannes Hospital Medizinische Klinik I	Dortmund
Germany	Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden	Dresden
Germany	Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie	Goettingen
Germany	Universitaeres Herzzentrum Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	St. Vincenz Krankenhaus	Limburg
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz
Germany	Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach	Munich
Greece	General Hospital of Athens "Georgios Gennimatas"	Athens
Greece	General Hospital of Attiki KAT	Athens
Greece	University General Hospital of Patra	Rio Patra
Hungary	Budai Irgalmasrendi Korhaz, Kardiologia	Budapest
Hungary	Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly	Gyor
Hungary	Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia	Nyiregyhaza
Hungary	Zala Megyei Korhaz, Kardiologia	Zalaegerszeg
Netherlands	Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark	Amsterdam
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Poland	Katedra i Klinika Kardiologii i Chorob Wewnetrznych	Bydgoszcz
Poland	Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.	Oswiecim
Poland	Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu	Wroclaw
Slovakia	Stredoslovensky ustav srdcovych a cievnych chorob, a.s.	Banska Bystrica
Slovakia	Narodny ustav srdcovych a cievnych chorob, a.s.	Bratislava
Slovakia	Univerzitna nemocnica Martin	Martin
Slovakia	Kardiocentrum Nitra, s.r.o.	Nitra
Slovakia	Vseobecna nemocnica Rimavska Sobota	Rimavska Sobota
Spain	"Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax	Barcelona
Spain	Hospital del Mar.	Barcelona
Spain	Hospital Del Sas de Jerez de La Frontera	Jerez de la Frontera	Cadiz
Spain	HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Hospital Universitari Son Espases	Palma de Mallorca
Spain	Hospital General Universitario de Valencia	Valencia
United Kingdom	City Hospital	Birmingham
United Kingdom	Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre	Blackpool	Lancashire
United Kingdom	Academic cardiology Unit	Cottingham Hull
United Kingdom	University Hospitals Coventry and Warwickshire NHS Trust	Coventry
United Kingdom	Ninewells Hospital and Medical School	Dundee
United Kingdom	Edinburgh Royal Infirmary	Edinburgh	Lothian
United Kingdom	The Queens Medical Research Institute- University of Edinburgh	Edinburgh
United Kingdom	University Hospital of Leicester (UHL) NHS Trust	Leicester
United Kingdom	Clinical Trials Unit Morriston Hospital	Swansea	Wales
United Kingdom	Clinical Trials Unit, Morriston Hospital	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Canada,  Czechia,  France,  Germany,  Greece,  Hungary,  Netherlands,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	0-24 months
Secondary	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.	0-24 months
Secondary	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.	0-24 months
Secondary	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.	0-24 months
Secondary	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.	0-24 months
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).	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.	0-24 months
Secondary	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.	0-24 months
Secondary	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.	0-24 months
Secondary	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.	6 months
Secondary	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.	0-24 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months

External Links

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