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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01176968
First received: August 4, 2010
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Myocardial Infarction
Drug: Eplerenone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to 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 [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to cardiovascular mortality [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to diagnosis of heart failure [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to first and each subsequent episode (after an event free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to first recorded ejection fraction of ≤ 40% (recorded 1 month or later post-randomization). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to 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). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to decision to provide an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Time to second or subsequent non-fatal myocardial infarction. [ Time Frame: 0-`23 months ] [ Designated as safety issue: No ]
  • QRS duration at 6 months post-randomization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Left atrial diameter (recorded on each occasion an echocardiogram is conducted). [ Time Frame: 0-23 months ] [ Designated as safety issue: No ]
  • Change in serum levels of biomarkers at 6 months post-randomization. Blood samples for biomarkers will be stored and analyzed post completion of the study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1013
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplerenone plus standard of care 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.
Other Name: Inspra
Placebo Comparator: Placebo plus standard of care
Matching placebo for eplerenone 25mg film coated tablets.
Drug: Placebo
Matching placebo tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01176968

  Hide Study Locations
Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital, Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada, V5Z 1M9
Diamond Health Care Centre (DHCC)
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Newfoundland and Labrador
Health Sciences Center, Division of Cardiology
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi
Chicoutimi, Quebec, Canada, G7H 7P2
Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Czech Republic
Fakultni nemocnice Brno
Brno, Czech Republic, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
I.Interni klinika-kardiologie FN Olomouc
Olomouc, Czech Republic, 775 20
Klinika kardiologie IKEM
Praha 4, Czech Republic, 140 21
Nemocnice Na Homolce - kardiologicke oddeleni
Praha 5, Czech Republic, 150 30
France
Chu Rangueil
Toulouse, Cedex 4, France, 31403
Hopital De La Pitie Salpetriere
Paris, Cedex, France, 75013
Service Cardiologie
Cannes, France, 06401
Physiologie Exploration Fonctionnelles
Creteil, France, 94010
Chu du Bocage - Centre de Cardiologie
Dijon, France, 21034 CEDEX
Centre de Caridologie d'Evecquemont Service de cardiologie 3ème étage
Evecquemont, France, 78740
Service Cardiologie
Libourne, France, 33500
Cardiologie Interventionnelle
Pessac Cedex, France, 33604
Germany
Universitaets-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany, 79189
Charite - Universitaetsmedizin Berlin
Berlin, Germany, 12200
Universitaetsklinikum Bonn
Bonn, Germany, 53127
Klinikum Links der Weser gGmbH
Bremen, Germany, 28277
Sankt Johannes Hospital
Dortmund, Germany, 44137
Medizinische Fakultaet ""Carl Gustav Carus"" Technische Universitaet Dresden
Dresden, Germany, 01309
Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie
Goettingen, Germany, 37075
Universitaeres Herzzentrum Hamburg
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
St. Vincenz Krankenhaus
Limburg, Germany, 65549
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany, 55131
Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach
Muenchen, Germany, 81737
Greece
University General Hospital of Patra
Rio, Patra, Greece, 26500
General Hospital of Athens ''G. Gennimatas''
Athens, Greece, 11527
General Hospital of Attiki KAT
Athens, Greece, 14561
Hungary
Budai Irgalmasrendi Korhaz, Kardiologia
Budapest, Hungary, 1027
Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly
Gyor, Hungary, 9024
Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Kft., Kardiologia
Nyiregyhaza, Hungary, 4400
Zala Megyei Korhaz, Kardiologia
Zalaegerszeg, Hungary, 8900
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 AC
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Poland
Katedra i Klinika Kardiologii i Chorob Wewnetrznych
Bydgoszcz, Poland, 85-094
Oddzial Kardiologiczny
Olsztyn, Poland, 10-561
Centrum Kardiologii Invazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu
Oswiecim, Poland, 32-600
Oddzial Kardiologiczny
Wroclaw, Poland, 51-124
Slovakia
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
Banska Bystrica, Slovakia, 974 01
Narodny ustav srdcovych a cievnych chorob, a.s.
Bratislava, Slovakia, 833 48
Martinska Fakultna Nemocnica
Martin, Slovakia, 036 59
Kardiocentrum Nitra, s.r.o.
Nitra, Slovakia, 949 01
Vseobecna nemocnica Rimavska Sobota
Rimavska Sobota, Slovakia, 979 12
Spain
Hospital Del Sas de Jerez de La Frontera
Jerez de La Frontera, Cadiz, Spain, 11407
Hospital Del Mar
Barcelona, Spain, 08003
Hospital Clinic i Provincial de Barcelona. Instituto Clinic del Torax
Barcelona, Spain, 08036
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario de La Paz
Madrid, Spain, 28046
Hospital Son Dureta
Palma de Mallorca, Spain, 07014
Hospital General Universitario de Valencia
Valencia, Spain, 46014
United Kingdom
Academic cardiology Unit
Cottingham, Hull, United Kingdom, HU16 5JQ
Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre
Blackpool, Lancashire, United Kingdom, FY3 8NR
Edinburgh Royal Infirmary
Edinburgh, Lothian, United Kingdom, EH16 4SA
Clinical Trials Unit
Swansea, Wales, United Kingdom, SA6 6NL
City Hospital, Ascot Clinic
Birmingham, United Kingdom, B18 7QH
University Hospitals Coventry and Warwickshire NHS Trust/ Department of Cardiology
Coventry, United Kingdom, CV2 2DX
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01176968     History of Changes
Other Study ID Numbers: A6141116
Study First Received: August 4, 2010
Last Updated: March 14, 2013
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
Eplerenone
myocardial infarction
mortality
morbidity

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Eplerenone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014