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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03686696
Ethics application status
Date submitted
3/09/2018
Date registered
27/09/2018
Date last updated
25/04/2019

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

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 - A Composite of time to all-cause Death and time to re-admission because of AMI, ischemic stroke or heart failure
Timepoint [1] 0 0
Time to event from the date of enrollment through study complition, 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 complition, 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
Gender
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 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

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Sout Austral
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

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
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%.
Trial website
https://clinicaltrials.gov/show/NCT03686696
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Terese Karlin, MSc Pharm
Address 0 0
Country 0 0
Phone 0 0
+46 18 617 04 36
Fax 0 0
Email 0 0
terese.karlin@ucr.uu.se
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03686696