Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
NCT ID: NCT01176968
Last Updated: 2020-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
1012 participants
INTERVENTIONAL
2010-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Eplerenone plus standard of care
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 plus standard of care
Matching placebo for eplerenone 25mg film coated tablets.
Placebo
Matching placebo tablets
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta, 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, Canada
Health Sciences Center, Eastern Health
St. John's, Newfoundland and Labrador, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, 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
Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont
Sherbrooke, Quebec, Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
I.Interni klinika-kardiologie FN Olomouc
Olomouc, , Czechia
I. Interni klinika - kardiologie FN Olomouc
Olomouc, , Czechia
Klinika kardiologie IKEM
Prague, , Czechia
Nemocnice Na Homolce - kardiologicke oddeleni
Prague, , Czechia
Chu Rangueil Service de Cardiologie, A - Bat H1
Toulouse, Cedex 4, France
Chu du Bocage - Centre de Cardiologie
Dijon, Cedex, France
Hopital De La Pitie Salpetriere
Paris, Cedex, France
Service Cardiologie, Centre Hospitalier de Cannes
Cannes, , France
Hôpital Henri Mondor - Pysiologie explorations fonctionnelles
Créteil, , France
Hôpital Henri Mondor
Créteil, , France
Centre de Cardiologie d'Evecquemont
Évecquemont, , France
Service Cardiologie Hopital Robert Boulin
Libourne, , France
Cardiologie Interventionnelle
Pessac, , France
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 Medizinische Klinik I
Dortmund, , Germany
Sankt Johannes Hospital
Dortmund, , Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, , Germany
Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie
Göttingen, , Germany
Universitaeres Herzzentrum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
St. Vincenz Krankenhaus
Limburg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach
Munich, , Germany
General Hospital of Athens "Georgios Gennimatas"
Athens, , Greece
General Hospital of Attiki KAT
Athens, , Greece
University General Hospital of Patra
Rio Patra, , Greece
Budai Irgalmasrendi Korhaz, Kardiologia
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly
Győr, , Hungary
Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia
Nyíregyháza, , Hungary
Zala Megyei Korhaz, Kardiologia
Zalaegerszeg, , Hungary
Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark
Amsterdam, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
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.
Oświęcim, , Poland
Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu
Wroclaw, , Poland
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
Banská 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
Rimavská Sobota, , Slovakia
Hospital Del Sas de Jerez de La Frontera
Jerez de la Frontera, Cadiz, Spain
"Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax
Barcelona, , Spain
Hospital del Mar.
Barcelona, , 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, , Spain
Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre
Blackpool, Lancashire, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, Lothian, United Kingdom
Clinical Trials Unit Morriston Hospital
Swansea, Wales, United Kingdom
City Hospital
Birmingham, , 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
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, , United Kingdom
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-019844-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REMINDER
Identifier Type: OTHER
Identifier Source: secondary_id
A6141116
Identifier Type: -
Identifier Source: org_study_id
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