Myocardial infarction with non-obstructive coronary artery disease (MINOCA).
Conditions
Interventions
Trade Name: Triatec, 5 mg
Product Name: Triatec
Pharmaceutical Form: Tablet
INN or Proposed INN: Ramipril
CAS Number: 87333-19-5
Other descriptive name: RAMIPRIL
Concentration unit: mg milligram(s)
Co
Sponsors
Department of Medical Sciences, Uppsala Universitet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether ACEI/ARB compared to no ACEI/ARB, reduce the composite endpoint of deathof 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 LV systolic ejection fraction =40%.;Secondary Objective: To determine whether oral beta-blockade compared to no oral beta-blockade, and, and whether ACEI/ARB compared to no ACEI/ARB, in patients with MINOCA and with no clinical signs of heart failure and with LV systolic ejection fraction =40% reduce: •All-cause mortality •Cardiovascular mortality •Readmission because of AMI •Readmission because of ischemic stroke •Readmission because of heart failure •Readmission because of unstable angina pectoris •Readmission because of atrial fibrillation. ;Primary end point(s): Time to death of any cause, or readmission because of AMI, ischemic stroke or heart failure.;Timepoint(s) of evaluation of this end point: Time to event or admission to hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to: 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(s) of evaluation of this end point: a-b Time to event c-g Time to admission to hospital | — |
Countries
Australia, Norway, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactBertil Lindahl
Department of Medical Sciences, Uppsala Universitet
Outcome results
None listed