Clinical trial NCT01176968: Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: Eplerenone
myocardial infarction
mortality
morbidity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 1012
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: 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
timeFrame: 0-24 months
Secondary outcomes:
measure: Cardiovascular Mortality
timeFrame: 0-24 months
measure: Diagnosis of Heart Failure
timeFrame: 0-24 months
measure: First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.
timeFrame: 0-24 months
measure: First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).
timeFrame: 0-24 months
measure: 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).
timeFrame: 0-24 months
measure: Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).
timeFrame: 0-24 months
measure: Second or Subsequent Non-fatal Myocardial Infarction (MI).
timeFrame: 0-24 months
measure: Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.
timeFrame: 6 months
measure: Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).
timeFrame: 0-24 months
measure: Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.
timeFrame: 6 months
measure: Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.
timeFrame: 6 months
measure: Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.
timeFrame: 6 months
measure: Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.
timeFrame: 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Walter C Mackenzie Health Sciences Centre (WCM)
state: Alberta
city: Vancouver
country: Canada
facility: Diamond Health Care Centre (DHCC)
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Centennial Pavilion
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital, Vancouver Coastal Health Authority
state: British Columbia
city: St. John's
country: Canada
facility: Health Sciences Center, Eastern Health
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Chicoutimi
country: Canada
facility: Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)
state: Quebec
city: Chicoutimi
country: Canada
facility: ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont
state: Quebec
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: I.Interni klinika-kardiologie FN Olomouc
city: Olomouc
country: Czechia
facility: I. Interni klinika - kardiologie FN Olomouc
city: Praha 4
country: Czechia
facility: Klinika kardiologie IKEM
city: Praha 5
country: Czechia
facility: Nemocnice Na Homolce - kardiologicke oddeleni
city: Toulouse
country: France
facility: Chu Rangueil Service de Cardiologie, A - Bat H1
state: Cedex 4
city: Dijon
country: France
facility: Chu du Bocage - Centre de Cardiologie
state: Cedex
city: Paris
country: France
facility: Hopital De La Pitie Salpetriere
state: Cedex
city: Cannes
country: France
facility: Service Cardiologie, Centre Hospitalier de Cannes
city: Creteil
country: France
facility: Hôpital Henri Mondor - Pysiologie explorations fonctionnelles
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Evecquemont
country: France
facility: Centre de Cardiologie d'Evecquemont
city: Libourne
country: France
facility: Service Cardiologie Hopital Robert Boulin
city: Pessac Cedex
country: France
facility: Cardiologie Interventionnelle
city: Bad Krozingen
country: Germany
facility: Universitaets-Herzzentrum Freiburg Bad Krozingen
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Bremen
country: Germany
facility: Klinikum Links der Weser gGmbH
city: Dortmund
country: Germany
facility: Sankt Johannes Hospital Medizinische Klinik I
city: Dortmund
country: Germany
facility: Sankt Johannes Hospital
city: Dresden
country: Germany
facility: Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
city: Goettingen
country: Germany
facility: Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie
city: Hamburg
country: Germany
facility: Universitaeres Herzzentrum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Limburg
country: Germany
facility: St. Vincenz Krankenhaus
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Munich
country: Germany
facility: Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach
city: Athens
country: Greece
facility: General Hospital of Athens "Georgios Gennimatas"
city: Athens
country: Greece
facility: General Hospital of Attiki KAT
city: Rio Patra
country: Greece
facility: University General Hospital of Patra
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz, Kardiologia
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz, Kardiologia
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Bydgoszcz
country: Poland
facility: Katedra i Klinika Kardiologii i Chorob Wewnetrznych
city: Olsztyn
country: Poland
facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Oswiecim
country: Poland
facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.
city: Wroclaw
country: Poland
facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu
city: Banska Bystrica
country: Slovakia
facility: Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob, a.s.
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nitra
country: Slovakia
facility: Kardiocentrum Nitra, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Vseobecna nemocnica Rimavska Sobota
city: Jerez de la Frontera
country: Spain
facility: Hospital Del Sas de Jerez de La Frontera
state: Cadiz
city: Barcelona
country: Spain
facility: "Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax
city: Barcelona
country: Spain
facility: Hospital del Mar.
city: Madrid
country: Spain
facility: HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre
state: Lancashire
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
state: Lothian
city: Swansea
country: United Kingdom
facility: Clinical Trials Unit Morriston Hospital
state: Wales
city: Birmingham
country: United Kingdom
facility: City Hospital
city: Cottingham Hull
country: United Kingdom
facility: Academic cardiology Unit
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
city: Edinburgh
country: United Kingdom
facility: The Queens Medical Research Institute- University of Edinburgh
city: Leicester
country: United Kingdom
facility: University Hospital of Leicester (UHL) NHS Trust
city: Swansea
country: United Kingdom
facility: Clinical Trials Unit, Morriston Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.