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

Study acronym: StratMedMINOCA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 16, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment target: 350 to 400
    • Study description expanded, about 133 words
    • Study title expanded, about 7 words
    v6
  2. Minor Secondary endpoints: 7 to 17
    • Study description expanded, about 169 words
    • Site contacts updated at 1 of 2 sites
    • Publications: 7 to 8
    v5
  3. Minor Study sites: 1 to 2v4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary and study completion dates: Feb 1, 2025 to Jul 31, 2026
    • Start date changed from estimate of Feb 1, 2022 to Feb 4, 2022
    • Study description expanded, about 19 words
    • Site details revised
  5. Minor Secondary endpoints: 6 to 7
    • Eligibility criteria expanded, about 3 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 the ward. Small vessel disease will be assessed using a 'diagnostic' guidewire during the standard angiogram. People with small vessel problems will be invited to participate in a clinical trial of usual care or eplerenone. Coronary microvascular dysfunction is defined as an index of microvascular resistance ≥25. Coronary flow reserve (CFR abnormal \<2.0), microvascular resistance reserve ratio (MRR, abnormal \<2.5), and resistance reserve ratio (RRR abnormal \<2.0), measured simultaneously with IMR, are predefined parameters of interest. Patients will be allocated into one of the 3 groups: * Group 1: Patients without coronary microvascular dysfunction. No eplerenone * Group 2: Patient with coronary microvascular dysfunction. Usual care, no eplerenone. * Group 3: Small vessels abnormal. Eplerenone tablets. The primary outcome for the trial will be reduced heart injury (biomarkers) in patients with microvascular disease. We will also test heart function (MRI scan) at enrolment and at six months. All patients (Groups 1, 2 and 3) will have an angiogram. Standard blood tests will be collected during the hospital stay, and then again at 1 and 6 months. Other outcomes include questionnaires (health status). We will gather information on longer-term health outcomes (hospitalisation, death) using confidential electronic record linkage. We will ask for permission to store blood samples for future research. The research will improve scientific knowledge about eplerenone therapy in this patient group. The study will create a repository of clinical samples and images which will provide vital data for studies of endotypes of myocardial infarction or injury with no obstructive coronary arteries.
Trial Details
NCT Number NCT05198791
Lead Sponsor NHS National Waiting Times Centre Board
Collaborators: British Heart Foundation, Abbott
Conditions
(from sponsor)
Myocardial Infarction, Acute, Myocardial Infarction With Nonobstructive Coronary Arteries, Myocardial Injury
Related terms MINOCA, Myocardial Infarction
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov