Status:
RECRUITING
Stratified Medicine of Eplerenone in Acute MI/Injury (StratMed-MINOCA)
Lead Sponsor:
NHS National Waiting Times Centre Board
Collaborating Sponsors:
British Heart Foundation
Abbott
Conditions:
Myocardial Infarction, Acute
Myocardial Infarction With Nonobstructive Coronary Arteries
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with heart attack or heart injury are tested (angiogram) for blockages in their arteries. Many patients develop heart problems caused by damage to small (microvascular) blood vessels. These i...
Detailed Description
Background: Myocardial infarction with non-obstructive coronary arteries (MINOCA) involves vascular dysfunction, prognosis is impaired and specific treatments are lacking. Mineralocorticoid antagonist...
Eligibility Criteria
Inclusion
- 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
- (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.
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05198791
Start Date
February 4 2022
End Date
July 31 2026
Last Update
February 20 2026
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Hairmyres
East Kilbride, Lanarkshire, United Kingdom, G75 8RG
2
Golden Jubilee National Hospital
Glasgow, United Kingdom