Stratified Medicine of Eplerenone in Acute MI/injury (StratMed-MINOCA)

Launched by NHS NATIONAL WAITING TIMES CENTRE BOARD · Jan 6, 2022

Keywords

ClinConnect Summary

The StratMed-MINOCA clinical trial is studying a medication called eplerenone to see how it can help patients who have experienced a heart attack or heart injury, especially those with damage to small blood vessels. This type of damage can happen in patients who also have COVID-19. The trial will involve patients who come to the Golden Jubilee hospital with suspected heart issues. If they are eligible, they will be divided into three groups: one group will not receive eplerenone, another will get standard care without eplerenone, and the last group will take eplerenone tablets. The main goal is to see if eplerenone can reduce heart damage and improve heart function over time.

To be eligible for the trial, patients need to be at least 18 years old and must have had a heart attack or heart injury without any major blockages in their arteries. They should also have at least one cardiovascular risk factor, such as being over 70, having diabetes, or being a smoker. Participants will undergo tests including an angiogram (a type of imaging to check the blood vessels) and will have their heart health monitored through blood tests and MRI scans at the beginning and six months later. This research aims to enhance understanding of how eplerenone works in these patients and will also collect samples for future studies related to COVID-19.

Gender

ALL

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.