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โ† Trials
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Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

RecruitingPhase 2Ages 18 Years - anyAllNHS National Waiting Times Centre Board
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In plain words

What the trial is, and whether it could suit you

Patients with heart attack or heart injury are tested (angiogram) for blockages in their arteries. Patients may develop heart problems caused by damage to small (microvascular) blood vessels. Eplerenone, a mineralocorticoid receptor-selective antagonist, reduces blood vessel injury and is used to treat high blood pressure and heart failure. Aim: to test the use of eplerenone in patients with heart attack/heart injury an no obstructive coronary arteries and small vessel problems (coronary microvascular dysfunction). Patients admitted to hospitals in the West of Scotland (2.5 million) and referred for invasive management to the Golden Jubilee and Hairmyres hospitals because of a suspected heart attack heart will be invited to participate into a registry-based clinical trial. Screening, enrolment and verbal, informed consent will be obtained during the angiogram then written consent on th

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years. * Acute myocardial infarction or myocardial injury and no obstructive coronary arteries. * Cardiovascular risk factor (โ‰ฅ1): 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 โ‰ค40% 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.
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What it tests

  • Stratified medicine - Microvascular dysfunction and eplerenone therapy, tablets
  • Stratification and standard care
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Where

2 sites
University Hospital Hairmyres
East Kilbride, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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