Stratified Medicine of Eplerenone in Acute MI/Injury (StratMed-MINOCA)
Myocardial Infarction, Acute, Myocardial Infarction With Nonobstructive Coronary Arteries, Myocardial Injury
About this trial
This is an interventional treatment trial for Myocardial Infarction, Acute focused on measuring Stratified Medicine, Mineralocorticoid receptor antagonists, MINOCA, Myocardial injury, Myocardial infarction, Myocardial Infarction with Nonobstructive Coronary Arteries
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years.
- Acute myocardial infarction or myocardial injury and no obstructive coronary arteries.
- Cardiovascular risk factor (≥1): age >70 years, atrial fibrillation, diabetes, current smoker, eGFR 30 - 60 mL/ minute/1.73 m2, prior MI, treated hypertension or COVID-19 (confirmed or suspected)
- Coronary angiography.
Exclusion Criteria (trial):
- Obstructive coronary artery disease
- Left ventricular ejection fraction ≤40% with evidence of heart failure, following myocardial infarction.
- Estimated glomerular filtration rate <30 mL/ minute/1.73 m2
- Severe liver impairment
- Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test and who are unwilling or unable to follow the reproductive restrictions defined in the eligibility criteria and use highly effective contraception as defined in Appendix 2 for the duration of the study treatment and 30 days after last dose of study drug.
- Patients taking one of the following medicines :
- Pre-existing treatment with an MRA :
- Anti-fungal drugs (ketoconazole or itraconazole).
- Antiviral medication (nelfinavir or ritonavir).
- Antibiotics (clarithromycin or telithromycin).
- Nefazodone used to treat depression.
- The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)) together.
Exclusion Criteria (registry):
- Contra-indication to cardiovascular magnetic resonance imaging e.g. severe claustrophobia, metallic foreign body.
- Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree atrio-ventricular block and sick sinus syndrome.
- Lack of informed consent.
Sites / Locations
- Golden Jubilee National HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Eplerenone
Standard of care
Patients with MINOCA and an index of microvascular resistance (IMR) greater than or equal to 25 will be randomised to receive eplerenone (starting dose 25 mg, uptitrated to 50mg after two weeks) for six months or standard of care and research protocol study visits. Patients who are screened, give informed consent but are not randomized will enter a followup registry.
Patients with MINOCA and an index of microvascular resistance (IMR) greater than or equal to 25 will be randomised to receive eplerenone (starting dose 25 mg, uptitrated to 50 mg after two weeks) for six months or standard of care and research protocol study visits. Patients who are screened, give informed consent but are not randomized will enter a followup registry.