EUCTR2018-000889-11-ESActive, not recruitingPhase 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 enrollmentStarted: January 23, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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