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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2025
  • participants needed
    3500
  • sponsor
    Uppsala University
Updated on 25 January 2021

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%.

Description

Large-scale use of acute coronary angiography has revealed a large portion of AMI without angiographically obstructive (defined as 50% diameter stenosis) coronary artery disease (CAD). The term "myocardial infarction with non-obstructive coronary arteries" (MINOCA) has been coined for this entity. MINOCA occurs in 5-10% of all patients with AMI and these patients are younger and more often females compared to patients with AMI and obstructive CAD. The 1-year mortality after MINOCA was found to be 3.5% in the systematic review by Pasupathy et al.. There are no randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI. However, in an observational study with propensity score matched comparisons the risk of experiencing a Major Adverse Cardiac Event (MACE) was 18% lower in patients treated with ACEI/ARB compared to no ACEI/ARB; in patients on beta blockers compared to patients not using beta blockers there was a non-significant 14% reduction in MACE.

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 ACEI/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 LV systolic ejection fraction 40%.

PRIMARY ENDPOINT: Time to death of any cause or readmission because of myocardial infarction, ischemic stroke or heart failure.

SECONDARY ENDPOINTS:

Time to:

  • All-cause mortality
  • Cardiovascular mortality
  • Readmission because of AMI
  • Readmission because of ischemic stroke
  • Readmission because of heart failure
  • Readmission because of unstable angina pectoris
  • Readmission because of atrial fibrillation.
    Safety

Time to readmission because of:

  • AV-block II-III, hypotension, syncope or need for pacemaker
  • Acute kidney injury
  • Ventricular tachycardia/fibrillation

Details
Condition Myocardial Infarction With Non-obstructive Coronary Arteries, Myocardial Infarction With Non-obstructive Coronary Arteries, Myocardial Infarction With Non-obstructive Coronary Arteries, Myocardial Infarction With Non-obstructive Coronary Arteries, Myocardial Infarction With Non-obstructive Coronary Arteries
Treatment ARB, ACEI, Beta blocker
Clinical Study IdentifierNCT03686696
SponsorUppsala University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Myocardial Infarction With Non-obstructive Coronary Arteries?
Do you have any of these conditions: Do you have Myocardial Infarction With Non-obstructive Coronary Arteries??
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 as cause of the index event
Contraindications for beta-blockade
Contraindications for ACEI and ARB
Prior use of ACEI, ARB, or beta blockers, which must continue according to treating physician
New indication for beta-blockade or ACEI/ARB 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
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