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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03686696




Registration number
NCT03686696
Ethics application status
Date submitted
3/09/2018
Date registered
27/09/2018

Titles & IDs
Public title
Randomized Evaluation of Beta Blocker and ACEI/ARB Treatment in MINOCA Patients - MINOCA-BAT
Scientific title
Randomized Evaluation of Beta Blocker and Angiotensin Converting Enzyme Inhibitor (ACEI) /Angiotensin Receptor Blocker (ARB) Treatment in MINOCA Patients.
Secondary ID [1] 0 0
EudraCT number 2018-000889-11
Universal Trial Number (UTN)
Trial acronym
MINOCA-BAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction With Non-obstructive Coronary Arteries 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Beta blocker
Treatment: Drugs - ACEI
Treatment: Drugs - ARB

No intervention: No Beta blocker and no ACEI/ARB - No Beta blocker and no ACEI/ARB

Experimental: Beta blocker and ACEI/ARB - Beta blocker and either ACE inhibitor or Angiotensin receptor blocker

Experimental: Beta blocker alone - Beta blocker alone

Experimental: ACEI/ARB alone - Either ACE inhibitor or Angiotensin receptor blocker alone


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure
Timepoint [1] 0 0
Time to event from the date of enrollment through study completion, an average of 4 years.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
a All-cause death: Time to event from the date of enrollment through study completion, an average of 4 years.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2023
Sample size
Target
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
Sout Austral
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Lyell McEwin Hospital - Adelaide
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [4] 0 0
Gold Coast Hospital - Gold Coast
Recruitment hospital [5] 0 0
Sunshine Hospital - Melbourne
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 0 0
Gosford Hospital - Sydney
Recruitment hospital [8] 0 0
John Hunter Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Gold Coast
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Norway
State/province [2] 0 0
Bergen
Country [3] 0 0
Norway
State/province [3] 0 0
Oslo
Country [4] 0 0
Spain
State/province [4] 0 0
Getafe
Country [5] 0 0
Spain
State/province [5] 0 0
Ourense
Country [6] 0 0
Spain
State/province [6] 0 0
Santiago De Compostela
Country [7] 0 0
Sweden
State/province [7] 0 0
Eskilstuna
Country [8] 0 0
Sweden
State/province [8] 0 0
Falun
Country [9] 0 0
Sweden
State/province [9] 0 0
Gävle
Country [10] 0 0
Sweden
State/province [10] 0 0
Göteborg
Country [11] 0 0
Sweden
State/province [11] 0 0
Halmstad
Country [12] 0 0
Sweden
State/province [12] 0 0
Helsingborg
Country [13] 0 0
Sweden
State/province [13] 0 0
Jönköping
Country [14] 0 0
Sweden
State/province [14] 0 0
Karlstad
Country [15] 0 0
Sweden
State/province [15] 0 0
Köping
Country [16] 0 0
Sweden
State/province [16] 0 0
Linköping
Country [17] 0 0
Sweden
State/province [17] 0 0
Lund
Country [18] 0 0
Sweden
State/province [18] 0 0
Malmö
Country [19] 0 0
Sweden
State/province [19] 0 0
Norrköping
Country [20] 0 0
Sweden
State/province [20] 0 0
Stockholm
Country [21] 0 0
Sweden
State/province [21] 0 0
Uppsala
Country [22] 0 0
Sweden
State/province [22] 0 0
Västerås
Country [23] 0 0
Sweden
State/province [23] 0 0
Örebro

Funding & Sponsors
Primary sponsor type
Other
Name
Uppsala University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Karolinska Institutet
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Göteborg University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Leeds
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Adelaide
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Oslo University Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
New York University
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bertil Lindahl, Prof
Address 0 0
Uppsala University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03686696