Randomized Evaluation of Beta Blocker and ACEI/ARB Treatment in MINOCA Patients - MINOCA-BAT

• Status: Recruiting
• Trial end date: 2026-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Myocardial infarction with non-obstructive coronary arteries" (MINOCA) occurs in 5-10% of all patients with AMI. There are neither any randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI, nor any treatment guidelines.

The primary objective of this multi-national, multi-center pragmatic randomized clinical trial is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether Angiotensin Converting Enzyme Inhibitors (ACEI/ Angiotensin Receptor Blockers (ARB) compared to no ACEI/ARB, reduce the composite endpoint of death of any cause and readmission because of AMI, ischemic stroke or heart failure in patients discharged with myocardial infarction with non-obstructive coronary artery disease (MINOCA) and with no clinical signs of heart failure and with left ventricular (LV) systolic ejection fraction ≥40%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University
• Collaborators: Göteborg University; Karolinska Institutet; New York University; Oslo University Hospital; University of Adelaide; University of Leeds
• Treatments: Adrenergic beta-Antagonists; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors

Criteria

Inclusion Criteria:

• Age >18 years.

• A clinical diagnosis of MINOCA within the last 30 days.

• Left ventricular ejection fraction ≥40% measured with echocardiography, MRI or left ventriculography after admission and prior to randomization.

• Written informed consent obtained

Exclusion Criteria:

• Any condition that may influence the patient's ability to comply with study protocol.

• Previous revascularization (CABG or PCI)

• Clinical signs of heart failure

• MRI-proven myocarditis or a strong clinical suspicion of myocarditis or takotsubo as cause of the index event

• Contraindications for Beta blocker treatment

• Contraindications for ACEI and ARB treatment

• Prior use of ACEI, ARB, or Beta blockers, which must continue according to treating physician.

• New indication for Beta blocker or ACEI/ARB treatment other than as secondary prevention according to treating physician

• Ongoing pregnancy or woman of childbearing potential not using adequate contraceptives

• Participation in a trial evaluating a drug known to interact with Beta blockers or ACEI/ARB