Myocardial infarction. We wish to test whether long-term treatment with betablocker (bisoprolol, carvedilol, metoprolol or nebivolol) leads to better prognosis than no treatment in patients suffering a myocardial infarction who do not have signs of heart failure MedDRA version: 20.0 Level: LLT Classification code 10028595 Term: Myocardial infarct System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Bisoprolol "Orion"
Product Name: Bisoprolol
Pharmaceutical Form: Tablet
INN or Proposed INN: bisoprololfumarat
Other descriptive name: BISOPROLOL FUMARATE
Concentration unit: mg milligr
Sponsors
Bispebjerg Frederiksberg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study the following inclusion criteria must be meet: • 18 years or older • Left ventricular ejection fraction (LVEF) > 40% • Myocardial infarction (MI) The diagnosis of acute MI must meet the Universal ESC definition of MI40: Detection of a rise and/or fall of cardiac biomarker values with at least one value above the 99th percentile upper reference limit and with at least one of the followings: • Symptoms of ischaemia. • New or presumed new significant ST-segment–T wave (ST–T) changes or new left bundle branch block (LBBB). • Development of pathological Q waves in the ECG. • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. The inclusion- and event rate in DANBLOCK have been continuously assessed since the first patient was randomized in December 2018. The inclusion and event rate have been lower than expected, in part due to COVID-19. To enhance feasibility, the decision was made by the Steering Committees to combine the data from DANBLOCK with the data from the Norwegian BETAMI (NCT03646357) and publish main results together. The trials have similar designs, only minor differences in study entry criteria, and were, from the very beginning, coordinated with the aim of conducting substudies on pooled data. The primary endpoint has been harmonized without knowledge of the distribution of events. 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. 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 1380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1380
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patient will be excluded if they meet any of the following criteria: • Clinical evidence of heart failure at the time of discharge • Pregnancy or of child bearing age not using safe anticonception • Signed informed consent and expected cooperation during follow-up Any medical condition where BB treatment is indicated according to the treating physician, which may include: • BB treated arrhythmias • BB treated hypertension • Cardiomyopathies • Seriously limited life-expectancy • Any condition (i.e. dementia) that could lead to increased risk for the patient when treated with BB-therapy Any contraindication to BB treatment according to the treating physician, which may include: • Hypotension • Bradyarrhythmias • Severe peripheral artery disease • History of not able to tolerate BB-therapy • Severe COPD • Severe valvular heart disease The exclusion is not limited to this list and the responsible treating physician will need consider if any other contraindication might exist for the patient. Both patients treated with a BB before their MI and patients in whom BB was initiated during the hospital admission are eligible for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether long-term treatment with oral betablocker therapy after myocardial infarction in patient with no heart failure reduces the composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary artery bypass graft, ischemic stroke, incident heart failure, malignant ventricular arrhythmia or resuscitated cardiac arrest.;Secondary Objective: Key secondary endpoints to be included in the main publication: • Each of the components of the primary endpoint, i.e.: All-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, malignant ventricular arrhythmia, or resuscitated cardiac arrest. • To assess clinical outcomes linked to beta-blocker therapy in the following subgroups: age, sex, BB dosage tertiles, STEMI vs. NSTEMI, and LVEF subgroups ;Primary end point(s): The composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary artery bypass graft, ischemic stroke, incident heart failure, malignant ventricular arrhythmia or resuscitated cardiac arrest.;Timepoint(s) of evaluation of this end point: Min 6 months after inclusion of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints to be included in the main publication: • Each of the components of the primary endpoint, i.e.: All-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, malignant ventricular arrhythmia, or resuscitated cardiac arrest. • To assess clinical outcomes linked to beta-blocker therapy in the following subgroups: age, sex, BB dosage tertiles, STEMI vs. NSTEMI, and LVEF subgroups Other secondary objectives: • To study whether oral beta-blocker therapy reduces the risk of cardiovascular death compared to no such therapy • To study whether oral beta-blocker therapy reduces the risk of stable and unstable angina compared to no such therapy • To study whether oral beta-blocker therapy reduces the risk of atrial fibrillation, atrial flutter or other atrial tachyarrhythmias compared to no such therapy • To study whether oral beta-blocker therapy increases the risk of hospitalization for bradycardia, syncope, implantation of pacemaker • To study whether oral beta-blocker therapy increases the risk of hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease. • To study whether oral beta-blocker therapy increases the risk of hospitalization or outpatient visit for new-onset or dysregulated diabetes • To study whether oral beta-blocker therapy affects the following patient related outcomes: Quality of life, angina, dyspnoea, anxiety, depression, sexual dysfunction or sleep disorders. • To conduct cost-utility analysis in relation to quality of life and a health economic evaluation including drug use, health care utilization, employment, income, and benefit take-up • To describe beta-blocker dosage and adherence • To assess study safety;Timepoint(s) of evaluation of this end point: 6 months - 6 years after MI PRO-questionnaires: at baseline, 3, 12, and 24 months Exercise capacity and blood pressure control: Before and after cardiac rehabilitati | — |
Countries
Denmark
Contacts
Public ContactDepartment of Cardiology
Bispebjerg Frederiksberg Hospital
Outcome results
None listed