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Danish trial of beta blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515748-22-01
Acronym
DANBLOCK
Enrollment
2760
Registered
2024-08-22
Start date
2018-12-01
Completion date
2025-04-01
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardinal infarction

Brief summary

The composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary atery bypass graft, ischemic stroke, incident heart faliure, malignant ventricular arrythmia or resuscitated cardiac arrest.

Detailed description

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, 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

Interventions

DRUGCarvedilol STADA 3
DRUG125 mg töflur.
DRUGMetoprololsuccinat "Polpharma"
DRUGCarvedilol STADA 12
DRUG5 mg töflur
DRUGCarvedilol STADA 25 mg töflur.
DRUGCarvedilol STADA 6
DRUGCarvedilol STADA® 12
DRUGBisoprolol Orion 2
DRUGBisoprolol Orion 5 mg tabletter
DRUGBisoprolol Orion 10 mg tabletter
DRUG25 mg töflur.
DRUG5 mg tabletti
DRUG25 mg tabletti
DRUG125 mg tabletti
DRUGCarvedilol STADA® 6
DRUGCarvedilol STADA 25 mg tabletti
DRUGCarvedilol STADA® 25 mg Tabletten
DRUGNebivolol Pliva 5 mg tablete
DRUG5 mg tabletit
DRUGBisoprolol Orion 10 mg tabletit
DRUGCarvedilol STADA 25 mg Tabletten
DRUGBisoprolol Orion 5 mg tabletit

Sponsors

Frederiksberg Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary atery bypass graft, ischemic stroke, incident heart faliure, malignant ventricular arrythmia or resuscitated cardiac arrest.

Secondary

MeasureTime frame
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, 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

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026