Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

NCT01176968 | Completed Phase 4 Results DMC

• 3 other identifiers: A61411162010-019844-38REMINDER
• Study Type: interventional
• Target: 1,012
• Locations: 11 countries
• Sites: 75

Brief Summary

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

Conditions

Myocardial Infarction

Keywords

Eplerenone; myocardial infarction; mortality; morbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Cardiovascular Mortality

  0-24 months

• Diagnosis of Heart Failure

  0-24 months

• First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.

  0-24 months

• First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).

  0-24 months

• 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).

  0-24 months

Study Arms (2)

Eplerenone plus standard of care

EXPERIMENTAL

Drug: Eplerenone

Placebo plus standard of care

PLACEBO COMPARATOR

Matching placebo for eplerenone 25mg film coated tablets.

Drug: Placebo

Interventions

Eplerenone DRUG

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.

Also known as: Inspra

Eplerenone plus standard of care

Placebo DRUG

Matching placebo tablets

Placebo plus standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (75)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Walter C Mackenzie Health Sciences Centre (WCM)

Edmonton, Alberta, T6G 2B7, Canada

Location

Diamond Health Care Centre (DHCC)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Vancouver General Hospital - Centennial Pavilion

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Vancouver General Hospital, Vancouver Coastal Health Authority

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Health Sciences Center, Eastern Health

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)

Chicoutimi, Quebec, G7H 5H6, Canada

Location

ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi

Chicoutimi, Quebec, G7H 7P2, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Fakultni nemocnice Brno

Brno, 62500, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

I.Interni klinika-kardiologie FN Olomouc

Olomouc, 775 20, Czechia

Location

I. Interni klinika - kardiologie FN Olomouc

Olomouc, 77520, Czechia

Location

Klinika kardiologie IKEM

Prague, 140 21, Czechia

Location

Nemocnice Na Homolce - kardiologicke oddeleni

Prague, 150 30, Czechia

Location

Chu Rangueil Service de Cardiologie, A - Bat H1

Toulouse, Cedex 4, 31403, France

Location

Chu du Bocage - Centre de Cardiologie

Dijon, Cedex, 21034, France

Location

Hopital De La Pitie Salpetriere

Paris, Cedex, 75013, France

Location

Service Cardiologie, Centre Hospitalier de Cannes

Cannes, 06401, France

Location

Hôpital Henri Mondor - Pysiologie explorations fonctionnelles

Créteil, 94010, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Centre de Cardiologie d'Evecquemont

Évecquemont, 78740, France

Location

Service Cardiologie Hopital Robert Boulin

Libourne, 33500, France

Location

Cardiologie Interventionnelle

Pessac, 33604, France

Location

Universitaets-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Charite - Universitaetsmedizin Berlin

Berlin, 12200, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Klinikum Links der Weser gGmbH

Bremen, 28277, Germany

Location

Sankt Johannes Hospital Medizinische Klinik I

Dortmund, 44137, Germany

Location

Sankt Johannes Hospital

Dortmund, 44137, Germany

Location

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, 01309, Germany

Location

Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie

Göttingen, 37075, Germany

Location

Universitaeres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

St. Vincenz Krankenhaus

Limburg, 65549, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131, Germany

Location

Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach

Munich, 81737, Germany

Location

General Hospital of Athens "Georgios Gennimatas"

Athens, 11527, Greece

Location

General Hospital of Attiki KAT

Athens, 14561, Greece

Location

University General Hospital of Patra

Rio Patra, 26500, Greece

Location

Budai Irgalmasrendi Korhaz, Kardiologia

Budapest, 1027, Hungary

Location

Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly

Győr, 9024, Hungary

Location

Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia

Nyíregyháza, 4400, Hungary

Location

Zala Megyei Korhaz, Kardiologia

Zalaegerszeg, 8900, Hungary

Location

Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark

Amsterdam, 1091 AC, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Katedra i Klinika Kardiologii i Chorob Wewnetrznych

Bydgoszcz, 85-094, Poland

Location

Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10-561, Poland

Location

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.

Oświęcim, 32-600, Poland

Location

Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu

Wroclaw, 51-124, Poland

Location

Stredoslovensky ustav srdcovych a cievnych chorob, a.s.

Banská Bystrica, 974 01, Slovakia

Location

Narodny ustav srdcovych a cievnych chorob, a.s.

Bratislava, 833 48, Slovakia

Location

Univerzitna nemocnica Martin

Martin, 036 59, Slovakia

Location

Kardiocentrum Nitra, s.r.o.

Nitra, 949 01, Slovakia

Location

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, 979 12, Slovakia

Location

Hospital Del Sas de Jerez de La Frontera

Jerez de la Frontera, Cadiz, 11407, Spain

Location

"Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax

Barcelona, 08036, Spain

Location

Hospital del Mar.

Barcelona, 8003, Spain

Location

HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07010, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre

Blackpool, Lancashire, FY3 8NR, United Kingdom

Location

Edinburgh Royal Infirmary

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Clinical Trials Unit Morriston Hospital

Swansea, Wales, SA6 6NL, United Kingdom

Location

City Hospital

Birmingham, B18 7QH, United Kingdom

Location

Academic cardiology Unit

Cottingham Hull, HU16 5JQ, United Kingdom

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Location

The Queens Medical Research Institute- University of Edinburgh

Edinburgh, EH16 4TJ, United Kingdom

Location

University Hospital of Leicester (UHL) NHS Trust

Leicester, LE3 GQP, United Kingdom

Location

Clinical Trials Unit, Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24780614 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 22, 2020
• Results First Posted: August 15, 2016

Record last verified: 2020-12

Locations

GB (10); PL (4); HU (4); CA (11); DE (13); GR (3); ES (7); SL (5); NL (2); CZ (7); FR (9)