Clinical trial exploring treatment benefits and safety of early administration of eplerenone in patients with heart attacks compared with placebo.
- Conditions
- ACUTE MYOCARDIAL INFARCTIONMedDRA version: 14.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-019844-38-CZ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1012
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study.
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.
STEMI is defined by:
1. Chest pain/discomfort lasting for 20 minutes or more of ischaemic characteristics (epigastric or interscapular are included).
2. ST segment elevation at the J point in two or more contiguous leads with the cut off points = 0.2 mv in leads V1, V2 or V3 and = 0.1 mv in other leads (contiguity in the frontal plane is defined by the lead sequence aVL, I, inverted aVR, II, aVF, III).
or New left bundle branch block.
3. Blood levels of cardiac enzymes are not required for a diagnosis of STEMI; however, if levels are available at time of randomization, then Troponin (I or T) OR creatine kinase (CK-MB, gender specific values should be used) must exceed the 99th percentile of normal of the laboratory performing the assay. Subjects randomized without subsequently elevated cardiac enzymes will continue in the study. A separate subgroup analysis will be performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 708
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 304
Subjects presenting with any of the following will not be included in the study:
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 (see Appendix 3 of the protocol).
19. Concomitant use of cytochrome p450 3A4 (CYP3A4) inducers, such as but not limited to: St. John’s wort; rifampin; carbamazepine; phenytoin; phenobarbitol (see Appendix 3 of the protocol).
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 fo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method