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

November 21, 2023 updated by: Uppsala University

Randomized Evaluation of Beta Blocker and Angiotensin Converting Enzyme Inhibitor (ACEI) /Angiotensin Receptor Blocker (ARB) Treatment in MINOCA Patients.

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%.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • The Lyell McEwin Hospital
      • Adelaide, Australia
        • The Queen Elizabeth Hospital
      • Gold Coast, Australia
        • Gold Coast Hospital
      • Melbourne, Australia
        • Sunshine Hospital
      • Perth, Australia
        • Royal Perth Hospital
      • Sydney, Australia
        • Gosford Hospital
      • Sydney, Australia
        • John Hunter Hospital
    • Sout Australi
      • Adelaide, Sout Australi, Australia
        • Royal Adelaide Hospital
  • New Zealand
      • Auckland, New Zealand
        • Auckland University Hospital
  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Oslo, Norway
        • Oslo University Hospital
  • Spain
      • Getafe, Spain
        • Getafe University Hospital
      • Ourense, Spain
        • C.H.U. Ourense
      • Santiago De Compostela, Spain
        • C.H. Universitario de Santiago
  • Sweden
      • Eskilstuna, Sweden
        • Mälardalens sjukhus Eskilstuna
      • Falun, Sweden
        • Falu Lasarett
      • Gävle, Sweden
        • Gavle Sjukhus
      • Göteborg, Sweden
        • Sahlgrenska Universitetssjukhus, Sahlgrenska
      • Halmstad, Sweden
        • Hallands Sjukhus
      • Helsingborg, Sweden
        • Helsingborg Lasarett
      • Jönköping, Sweden
        • Ryhovs sjukhus
      • Karlstad, Sweden
        • Centralsjukhuset Karlstad
      • Köping, Sweden
        • Västmanlands sjukhus Köping
      • Linköping, Sweden
        • Universitetssjukhuset i Linköping
      • Lund, Sweden
        • Skånes universitetssjukhus Lund
      • Malmö, Sweden
        • Skånes universtitetssjukhus Malmö
      • Norrköping, Sweden
        • Vrinneviesjukhuset
      • Stockholm, Sweden
        • Danderyd Hospital
      • Stockholm, Sweden
        • Söderskjukhuset
      • Uppsala, Sweden
        • Akademiska Sjukhuset
      • Västerås, Sweden
        • Västerås Lasarett
      • Örebro, Sweden
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Beta blocker and no ACEI/ARB
Experimental: Beta blocker and ACEI/ARB
Beta blocker and either ACE inhibitor or Angiotensin receptor blocker
Drug: Beta blocker
Patients randomized to beta-blockade will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Names:
  • Beta receptor blocker
Drug: ACEI
Patients randomized to ACE inhibitor will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Names:
  • ACE inhibitor
Drug: ARB
Patients randomized to Angiotensin receptor blockers will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications
Other Names:
  • Angiotensin receptor blocker
Experimental: Beta blocker alone
Drug: Beta blocker
Patients randomized to beta-blockade will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Names:
  • Beta receptor blocker
Experimental: ACEI/ARB alone
Either ACE inhibitor or Angiotensin receptor blocker alone
Drug: ACEI
Patients randomized to ACE inhibitor will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
Other Names:
  • ACE inhibitor
Drug: ARB
Patients randomized to Angiotensin receptor blockers will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications
Other Names:
  • Angiotensin receptor blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure
Time Frame: Time to event from the date of enrollment through study completion, an average of 4 years.
A Composite of time to all-cause Death and time to re-admission because of AMI, ischemic stroke or heart failure
Time to event from the date of enrollment through study completion, an average of 4 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
a All-cause death b Cardiovascular death c Readmission because of AMI d Readmission because of ischemic stroke e Readmission because of heart failure f Readmission because of unstable angina pectoris g Readmission because of atrial fibrillation.
Time Frame: a All-cause death: Time to event from the date of enrollment through study completion, an average of 4 years.
a All-cause death: Time to event from the date of enrollment through study completion, an average of 4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet
Oslo University Hospital
Göteborg University
New York University
University of Leeds
University of Adelaide

Investigators

  • Study Chair: Bertil Lindahl, Prof, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2018

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

August 22, 2023

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number 2018-000889-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will make a limited, de-identified set of data available for researchers outside the primary investigators two years after the publication of the primary results of the study. Before data are shared, a data-sharing agreement should be established documenting what data are being shared and how the data can be used. The agreement serves two purposes. First, it protects the agency providing the data, ensuring that the data will not be misused. Second, it prevents miscommunication on the part of the provider of the data and the agency receiving the data by making certain that any questions about data use are discussed. The following items should be covered in the data-sharing agreement:

  • Period of agreement
  • Intended use of the data
  • Constraints on use of the data
  • Data confidentiality
  • Data security
  • Methods of data-sharing

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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