A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATING THE SAFETY AND EFFICACY OF EARLY TREATMENT WITH EPLERENONE IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTIO
- Conditions
- Heart attack10028593
- Registration Number
- NL-OMON36477
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Evidence of a personally signed and dated informed consent document obtained prior to the initiation of any study procedures and indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Subjects must be male or non-pregnant female aged >=18 years of age at the time informed consent is obtained.
4. If the subject is female, she must be post-menopausal,or is surgically sterile, and is not lactating.
5. Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.
1. The subject has received any investigational medication or used any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug or device study, or is scheduled to receive an investigational drug other than eplerenone or to use an investigational device during the course of the study.
2. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Subjects who have experienced a previous myocardial infarction may be included provided all other inclusion / exclusion criteria are met.
3. Subjects with inability to follow protocol procedures according to the investigation.
4. The subject has any condition which, in the opinion of the Investigator, makes participation in this study not in the best interest of the subject.
5. The subject has a severe organic disorder or has had surgery or disease of the gastrointestinal tract which, in the opinion of the Investigator, may interfere with the absorption, pharmacokinetics, or elimination of the study drug.
6. The subject has a co-morbid condition that would be expected to result in death during the next year (eg, terminal cancer, AIDS, etc) including subjects receiving immunosuppressive or antineoplastic therapy.
7. The subject has current evidence of alcohol or drug abuse problems, which in the Investigator's opinion, precludes study participation.
8. Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.
9. The subject has an implanted cardiac defibrillator (ICD).
10. The subject is awaiting cardiac transplant.
11. The subject has uncontrolled hypotension (SBP<90mmHg).
12. Subjects with eGFR <=30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine >=220µmol/L.
13. Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.
14. Patients who have haemodynamically relevant aortic or mitral valve stenosis as judged by the investigator.
15. Subjects with a diagnosis of hypertrophic cardiomyopathy.
16. Subjects who have had cardiac surgery within 30 days prior to randomization.
17. Concomitant use of potassium sparing diuretics (eg, spironolactone, triamterene or amiloride) or subjects who in the opinion of the investigator require treatment with potassium sparing diuretics. Use of potassium preparations or supplements will be allowed on a case by case basis at the discretion of the Investigator.
18. Concomitant use of potent cytochrome p450 3A4 (CYP3A4) inhibitors, such as but not limited to: ketoconazole; itraconazole; nefazodone; troleandomycin; clarithromycin; ritonavir; nelfinavir.
19. Concomitant use of cytochrome p450 3A4 (CYP3A4) inducers, such as but not limited to: St. John*s wort; rifampin; carbamazepine; phenytoin; phenobarbitol.
20. Subjects who are likely to require treatment during the trial period with drugs not permitted by this protocol.
21. Subjects with preexisting significant hepatic disease (for example, known positive serology for viral hepatitis) or aspartate aminotransferase (AST) and/or alanine aminotransferas
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint:<br /><br>Time to first event of :<br /><br>- Cardiovascular mortality<br /><br>- Re-hospitalization or extended initial hospital stay due to diagnosis of<br /><br>heart failure<br /><br>- Sustained ventricular tachycardia or fibrillation<br /><br>- Ejection fraction <= 40% after 1 month or BNP >200 pg/ml or NT-proBNP >450<br /><br>pg/ml (age<50 years); >900 pg/ml (age 50-75 years) or >1800 pg/ml (age>75<br /><br>years) after 1 month.</p><br>
- Secondary Outcome Measures
Name Time Method