Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT01176968

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:

MedlinePlus related topics: Heart Attack Heart Failure

Drug Information available for: Eplerenone

U.S. FDA Resources

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. [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to cardiovascular mortality [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
Time to diagnosis of heart failure [ Time Frame: 0-18 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: 0-18 months ] [ Designated as safety issue: No ]
Time to first recorded ejection fraction of ≤ 40% (recorded 1 month or later post-randomization). [ Time Frame: 0-18 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: 0-18 months ] [ Designated as safety issue: No ]
Time to decision to provide an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT). [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
Time to second or subsequent non-fatal myocardial infarction. [ Time Frame: 0-`18 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: 0-18 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 ]

Estimated Enrollment:	612
Study Start Date:	September 2010
Estimated Study Completion Date:	October 2012
Estimated 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176968

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 68 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01176968 History of Changes
Other Study ID Numbers:	A6141116
Study First Received:	August 4, 2010
Last Updated:	May 4, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Pfizer:

Eplerenone
myocardial infarction
mortality
morbidity

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012