Registry based randomized study of Beta blocker, ACE Inhibitor and Angiotensin Receptor Blocker in patients discharged with myocardial infarction with non-obstructive coronary artery disease (MINOCA-BAT)
- Conditions
- Myocardial infarction with non-obstructive coronary artery disease (MINOCA).Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-000889-11-ES
- Lead Sponsor
- Department of Medical Sciences, Uppsala Universitet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 3500
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method