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About
The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).
Full description
This is a prospective, randomized, open blinded end-point (PROBE) study. Patients with AMI will be randomized 1-8 days following PCI or thrombolysis, and allocated to either prescription of a BB or to no such prescription. Subjects will be followed up for at least 6 months (median 3 years) with respect to the primary and secondary endpoints.
The primary objective is to test whether oral BB therapy reduces the risk of all-cause death, recurrent MI, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia or resuscitated cardiac arrest compared to no such therapy, in patients with AMI treated with PCI or thrombolysis without reduced LVEF.
The key secondary objectives are:
Other secondary objectives are:
quality of life, angina, dyspnoea, anxiety, depression, sexual dysfunction or sleep disorders
Exploratory objectives:
The primary study end-points will be obtained through linkage to the Norwegian Cardiovascular Disease Registry and The Norwegian Population Registry (Folkeregisteret)
Secondary endpoints will be obtained by linkage to the following national registries: The Norwegian Population Registry (Folkeregisteret), the Cause of Death Registry, the Norwegian Patient Registry, the Norwegian Cardiovascular Disease Registry, the Norwegian Prescription Database, the Norwegian registry for income, the FD-Trygd database (social security micro data for research) and the Control and payment of reimbursements to health service providers (KUHR) database. Further by collecting self-reported questionnaires and a clinical examination with blood sample collection.
Primary safety endpoints:
• To describe the composite endpoint of malignant ventricular arrhythmias or resuscitated cardiac arrest, incident heart failure, new MI or all-cause death at 30 days after randomization collected from i. direct telephone contact with the patient and from hospital medical records, ii. linkage to the Norwegian Cardiovascular Disease Registry and The Norwegian Population Registry at study end.
Other safery endpoints:
Rationale for combining data from the BETAMI study with the DANBLOCK (NCT03778554) study from Denmark: The trials have similar designs, only minor differences in study entry criteria, and were, from the very beginning, coordinated with the aim of conducting sub-studies on pooled data. However, the inclusion- and event rates have been lower than expected in both studies. To enhance feasibility, the final decision was made from both Steering Committees in March 2022 to combine the trials and publish initial results jointly. BETAMI and DANBLOCK will remain separate trials until the end of follow-up, where data from the trials will be combined and main results published together.
Sample size: A total of approximately 2900 patients from BETAMI will be recruited and randomized 1:1 to BB treatment (type and dosage according to treating physician) or no BB treatment within 8 days of MI. The study is event driven and a power calculation for the combined DANBLOCK-BETAMI trial has been performed in which 950 events will provide a power of 80% to detect a true treatment effect equal to a hazard ratio of 1.2 for no beta-blocker therapy. Follow-up: Patients will be followed from the randomization date until end of follow-up. The last patient included will be followed for a minimum of 6 months. Estimated mean (non) treatment duration is 3 (0.5-6) years.
Post-trial objective:
• To perform a joint analysis of the data from BETAMI-DANBLOCK with the REDUCE (NCT03278509) and REBOOT (NCT03596385) trials. This analysis will comprise approximately 19000 patients, giving increased power and precision for clinical decisions on both primary and secondary endpoints.
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Inclusion and exclusion criteria
Inclusion Criteria
To be eligible for inclusion in the study, subjects must fulfill the following criteria at inclusion:
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:
Contraindications to betablocker-therapy, including but not limited to:
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
Primary purpose
Allocation
Interventional model
Masking
2,895 participants in 2 patient groups
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Central trial contact
Arnhild Bakken, MD PhD; John Munkhaugen, MD PhD
Data sourced from clinicaltrials.gov
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