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Myocardial Infarction With Non-obstructive Coronary ArteriesPhase 4MINOCA-BATNCT03686696

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

A Phase 4 study testing Beta blocker, ACEI and ARB in people with Myocardial Infarction With Non-obstructive Coronary Arteries, run by Uppsala University at 32 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Beta blocker, ACEI and ARB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
32 sitesin 5 countries
Study dates
16 Dec 2018to 22 Aug 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

32 sites in 5 countries.

32 sites in 5 countries

Sweden18 sites

  • Mälardalens sjukhus Eskilstuna

    Eskilstuna

  • Falu Lasarett

    Falun

  • Gävle sjukhus

    Gävle

  • Sahlgrenska Universitetssjukhus, Sahlgrenska

    Gothenburg

  • Hallands sjukhus

    Halmstad

  • Helsingborg Lasarett

    Helsingborg

  • Ryhovs sjukhus

    Jönköping

  • Centralsjukhuset Karlstad

    Karlstad

  • Västmanlands sjukhus Köping

    Köping

  • Universitetssjukhuset i Linköping

    Linköping

  • Skånes Universitetssjukhus Lund

    Lund

  • Skånes universtitetssjukhus Malmö

    Malmö

  • Vrinneviesjukhuset

    Norrköping

  • Örebro University Hospital

    Örebro

  • Danderyd Hospital

    Stockholm

  • Söderskjukhuset

    Stockholm

  • Akademiska Sjukhuset

    Uppsala

  • Västerås Lasarett

    Västerås

Other trials in Sweden

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, Sout Australi

  • The Lyell McEwin Hospital

    Adelaide

  • The Queen Elizabeth Hospital

    Adelaide

  • Gold Coast Hospital

    Gold Coast

  • Sunshine Hospital

    Melbourne

  • Royal Perth Hospital

    Perth

  • Gosford Hospital

    Sydney

  • John Hunter Hospital

    Sydney

Other trials in Australia

Spain3 sites

  • Getafe University Hospital

    Getafe

  • C.H.U. Ourense

    Ourense

  • C.H. Universitario de Santiago

    Santiago de Compostela

Other trials in Spain

Norway2 sites

  • Haukeland University Hospital

    Bergen

  • Oslo University Hospital

    Oslo

Other trials in Norway

New Zealand1 site

  • Auckland University Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: 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%.

Read the 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
Being tested
Beta blocker, ACEI, ARB
Keywords
Myocardial infarction, Treatment, ACE inhibitors, Angiotensin receptor blockade, Beta blockers
Medical subject headings
MINOCA, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beta blockerDrug

    Also called Beta receptor 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.

  • ACEIDrug

    Also called ACE inhibitor

    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.

  • ARBDrug

    Also called Angiotensin receptor blocker

    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

Study groups in NCT03686696
Study groupRoleWhat they receive
No Beta blocker and no ACEI/ARBNo interventionNo Beta blocker and no ACEI/ARB
Beta blocker and ACEI/ARBExperimentalBeta blocker and either ACE inhibitor or Angiotensin receptor blocker
Receives: Drug: Beta blocker; Drug: ACEI; Drug: ARB
Beta blocker aloneExperimentalBeta blocker alone
Receives: Drug: Beta blocker
ACEI/ARB aloneExperimentalEither ACE inhibitor or Angiotensin receptor blocker alone
Receives: Drug: ACEI; Drug: ARB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure

    A Composite of time to all-cause Death and time to re-admission because of AMI, ischemic stroke or heart failure

    Measured: Time to event from the date of enrollment through study completion, an average of 4 years.

Secondary outcomes (1)

  1. 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.

    Measured: a All-cause death: Time to event from the date of enrollment through study completion, an average of 4 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2018
  2. Study start16 Dec 2018
  3. Primary completion31 May 2023
  4. Study completion22 Aug 2023

Why it stopped: Low inclusion rate.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2 \* 2 Factorial Design
Masking
None (open label)
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03686696
Sponsor's protocol ID
EudraCT number 2018-000889-11
Acronym
MINOCA-BAT
Status last verified
Nov 2023
First submitted
3 Sep 2018
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Kumar D, Nirander F, Raza H, Rani S, Raj P, Adnan F, Malik J. Role of Personalized Medicine in Myocardial Infarction With Nonobstructive Coronary Artery Disease (MINOCA): An Updated Review. Cardiol Rev. 2026 Jul-Aug 01;34(4):322-327. doi: 10.1097/CRD.0000000000000707. Epub 2024 Apr 26.

    PubMed 42246870

  • Nordenskjold AM, Agewall S, Atar D, Baron T, Beltrame J, Bergstrom O, Erlinge D, Gale CP, Lopez-Pais J, Jernberg T, Johansson P, Ravn-Fisher A, Reynolds HR, Somaratne JB, Tornvall P, Lindahl B. Randomized evaluation of beta blocker and ACE-inhibitor/angiotensin receptor blocker treatment in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA-BAT): Rationale and design. Am Heart J. 2021 Jan;231:96-104. doi: 10.1016/j.ahj.2020.10.059. Epub 2020 Oct 24.

    PubMed 33203618

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beta blocker, ACEI and ARB in people with Myocardial Infarction With Non-obstructive Coronary Arteries, run by Uppsala University at 32 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Sweden, Australia, Spain, Norway, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low inclusion rate.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03686696, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.

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