Randomized Evaluation of Beta Blocker and ACEI/ARB Treatment in MINOCA Patients - MINOCA-BAT
NCT ID: NCT03686696
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
198 participants
INTERVENTIONAL
2018-12-16
2023-08-22
Brief Summary
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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%.
Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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No Beta blocker and no ACEI/ARB
No Beta blocker and no ACEI/ARB
No interventions assigned to this group
Beta blocker and ACEI/ARB
Beta blocker and either ACE inhibitor or Angiotensin receptor blocker
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.
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.
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
Beta blocker alone
Beta blocker alone
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.
ACEI/ARB alone
Either ACE inhibitor or Angiotensin receptor blocker alone
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.
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
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Göteborg University
OTHER
University of Leeds
OTHER
University of Adelaide
OTHER
Oslo University Hospital
OTHER
New York University
OTHER
Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Bertil Lindahl, Prof
Role: STUDY_CHAIR
Uppsala University
Locations
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Royal Adelaide Hospital
Adelaide, Sout Australi, Australia
The Lyell McEwin Hospital
Adelaide, , Australia
The Queen Elizabeth Hospital
Adelaide, , Australia
Gold Coast Hospital
Gold Coast, , Australia
Sunshine Hospital
Melbourne, , Australia
Royal Perth Hospital
Perth, , Australia
Gosford Hospital
Sydney, , Australia
John Hunter Hospital
Sydney, , Australia
Auckland University Hospital
Auckland, , New Zealand
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Getafe University Hospital
Getafe, , Spain
C.H.U. Ourense
Ourense, , Spain
C.H. Universitario de Santiago
Santiago de Compostela, , Spain
Mälardalens sjukhus Eskilstuna
Eskilstuna, , Sweden
Falu Lasarett
Falun, , Sweden
Gävle sjukhus
Gävle, , Sweden
Sahlgrenska Universitetssjukhus, Sahlgrenska
Gothenburg, , Sweden
Hallands sjukhus
Halmstad, , Sweden
Helsingborg Lasarett
Helsingborg, , Sweden
Ryhovs sjukhus
Jönköping, , Sweden
Centralsjukhuset Karlstad
Karlstad, , Sweden
Västmanlands sjukhus Köping
Köping, , Sweden
Universitetssjukhuset i Linköping
Linköping, , Sweden
Skånes Universitetssjukhus Lund
Lund, , Sweden
Skånes universtitetssjukhus Malmö
Malmo, , Sweden
Vrinneviesjukhuset
Norrköping, , Sweden
Örebro University Hospital
Örebro, , Sweden
Danderyd Hospital
Stockholm, , Sweden
Söderskjukhuset
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Västerås Lasarett
Västerås, , Sweden
Countries
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References
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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.
Other Identifiers
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EudraCT number 2018-000889-11
Identifier Type: -
Identifier Source: org_study_id