EUCTR2018-000889-11-SE
Active, not recruiting
Phase 1
Randomized Evaluation of Beta Blocker and ACE-Inhibitor/Angiotensin Receptor Blocker Treatment in MINOCA patients - MINOCA-BAT - MINOCA-BAT
Department of Medical Sciences, Uppsala Universitet0 sites3,500 target enrollmentApril 25, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myocardial infarction with non-obstructive coronary artery disease (MINOCA).
- Sponsor
- Department of Medical Sciences, Uppsala Universitet
- Enrollment
- 3500
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \>18 years.
- •2\.A clinical diagnosis of MINOCA within the last 30 days.
- •3\.Left ventricular ejection fraction \=40% measured with echocardiography, MRI or left ventriculography after admission and prior to randomization.
- •4\.Written informed consent obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 1750
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 1750
Exclusion Criteria
- •1\.Any condition that may influence the patient's ability to comply with study protocol.
- •2\.Previous revascularization (CABG or PCI)
- •3\.Clinical signs of heart failure
- •4\.MRI\-proven myocarditis or a strong clinical suspicion of myocarditis as cause of the index event
- •5\.Contraindications for beta\-blockade
- •6\.Contraindications for ACEI and ARB
- •7\.Prior use of ACE\-I, ARB, or beta blockers, which must continue according to Investigator.
- •8\.New indication for beta\-blockade or ACEI/ARB other than as secondary prevention according to Investigator.
- •9\.Ongoing pregnancy or woman of childbearing potential not using highly effective contraceptives
- •10\.Participation in a trial evaluating a drug known to interact with beta blockers or ACEI/ARB
Outcomes
Primary Outcomes
Not specified
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