Patients admitted to hospital with acute myocardial infarction treated With reperfusion therapy (i.e trombolysis or percutaneous coronary intervention)
Conditions
Interventions
Trade Name: Metoprolol succinate (trade names: Metoprolol sandoz, Betaloc zok, Selo-zok)
Bisoprolol (trade names: bisprolol , emconcor)
Carvedilol (trade name: Carvedilol )
Nebivolol (trade name: H
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 CAG) • 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 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 2500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2500
Exclusion criteria
Exclusion criteria: Study subjects must not meet any of the following criteria: • Having a condition where BB-therapy is required, including but not limited to: o Arrhythmias o Hypertension o Cardiomyopathies o Clinical diagnosis of heart failure o LVEF < 40% by echocardiography • Contraindications to BB-therapy: o Bradyarrhythmias o Hypotension o Severe peripheral artery disease o Previously known side-effects causing withdrawal o Severe chronic obstructive pulmonary disease o Others, according to the responsible investigator • Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion 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 • Women of childbearing potential using inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence. • Short life expectancy due to other medical conditions Previous treatment with a BB is not an exclusion criterion for enrollment into the BETAMI study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • Time to non-fatal MI, all-cause mortality, ventricular arrhythmias, hospitalization for heart failure, cardiovascular death • Income, employment status, drug use, health care utilization, and benefit take-up • Traditional cardiovascular risk factors, drug adherence, and self-reported side-effects Safety endpoint: • Rate of ventricular arrhythmias, heart failure, new MI or all-cause death 30 days after randomization;Timepoint(s) of evaluation of this end point: Secondary end-points: At study end after estimated 0.5-6.5 years for each patient Safety end-Points: Safety endpoints will be collected by direct telephone contact with the patient at 30 day after randomization | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to test whether oral BB therapy reduces the risk of all-cause death or non-fatal MI compared to no such therapy, in patients with AMI treated with PCI or thrombolysis and no clinical signs of heart failure and/or LVEF = 40%.;Secondary Objective: The key secondary objectives are: • To study whether oral BB therapy reduces the risk of each of the components of the primary end-point separately, compared to no such therapy • To study whether oral BB therapy reduces the risk of hospitalization for ventricular arrhythmias or heart failure compared to no such therapy • To study whether oral BB therapy reduces the risk of cardiovascular death compared to no such therapy • To conduct a health economic evaluation including drug use, health care utilization, employment, income, and benefit take-up • To compare sociodemographic, clinical, and psychosocial characteristics between the two study arms • To assess study safety • To assess efficacy between subgroups Post-trial objective: • To perform a joint analysis of the data with the REDUCE study (Sweden) and DANBLOCK (Denmark). This analysis will comprise 16500 patients, giving increased power and precision to make clinical decisions on both primary and secondary endpoints.;Primary end point(s): Primary endpoint: • Time to all-cause mortality or non-fatal MI ;Timepoint(s) of evaluation of this end point: At study end after estimated 0.5-6.5 years for each patient | — |
Countries
Norway
Contacts
Public Contactwill be completed during feb18
Oslo University Hospital
Outcome results
None listed