BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function (BETAMI)

2018-000590-75

The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).

2018-10-01

2024-12-10

2034-12-10

Active (not recruiting)

Early phase I

2895

Inclusion Criteria To be eligible for inclusion in the study, subjects must fulfill the following criteria at inclusion: * 18 years or older * Diagnosed with an acute MI type I according to the "Universal Definition of MI" (Defined as a detection of a rise and/or fall of cardiac biomarker value, preferably troponin, with at least one value above the 99th percentile upper reference limit and with at least one of the following; a) symptoms of ischemia, b) new or presumed new significant ST-segment-T wave changes or new left bundle branch block, c) development of pathological Q waves, d) imaging evidence of new loss of viable myocardium or e) identification of an intracoronary thrombus by coronary angiogram) * Must have been treated with PCI or thrombolysis during current hospitalization * Signed informed consent and expected cooperation of the patient according to ICH/GCP and national/local regulations * Have a national personal identification number and not be expected to emigrate during study Exclusion Criteria Study subjects must not meet any of the following criteria: * Having a condition where betablocker-therapy is required, including but not limited to: * Arrhythmias * Hypertension * Cardiomyopathies * Clinical diagnosis of heart failure * LVEF \< 40% by echocardiography (by measurement and not only visual assessment for STEMI patients) * Left ventricular akinesia in ≥ 3 segments regardless of the LVEF * Contraindications to betablocker-therapy, including but not limited to: * Bradyarrhythmias * Hypotension * Severe peripheral artery disease * Previously known side-effects causing withdrawal * Severe chronic obstructive pulmonary disease * • Women of childbearing potential (a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) * Known hypersensitivity to any ingredient of the IMP * Other, according to the responsible investigator * End-stage somatic disease with short life expectancy, dementia, psychosis and other conditions could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible Previous treatment with a betablocker is not an exclusion criterion for enrollment into the BETAMI study. Enrolled patients can participate in any other study that does not directly alter the effect betablocker treatment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PROBE - prospective, randomized, open blinded end-point', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2895, 'type': 'ACTUAL'}}

2024-03-01