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

Start 1 Dec 2018 · End 1 Apr 2025 · Status Ended · 1 EU/EEA countries · 25 sites · Protocol DANBLOCK

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ended

Participants planned 2,760

Countries 1

Sites 25

Myocardinal infarction

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.

Key facts

Sponsor: Frederiksberg Hospital
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 1 Dec 2018 → 1 Apr 2025
Decision date (initial): 2024-08-22
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Danish Heart Foundation · Novo Nordisk Foundation

External identifiers

EU CT number: 2024-515748-22-01
EudraCT number: 2018-002699-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

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 objectives 1

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

Conditions and MedDRA coding

Myocardinal infarction

Regulatory references

Plan to share IPD: No

EU CT number	Title	Sponsor
2024-515748-22-00	Danish trial of beta blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK)	Frederiksberg Hospital

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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.

Exclusion criteria 3

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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 endpoints 12

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 28

Bisoprolol Orion 10 mg tabletit

PRD507260 · Product

Active substance: Bisoprolol Fumarate
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 28522
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 5 mg tabletter

PRD507276 · Product

Active substance: Bisoprolol Fumarate
Substance synonyms: BUT-2-ENEDIOIC ACID: 1-(PROPAN-2-YLAMINO)-3-[4-(2-PROPAN-2-YLOXYETHOXYMETHYL)PHENOXY]PROPAN-2-OL
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 43905
MA holder: ORION CORPORATION
MA country: Sweden
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 5 mg tabletit

PRD507274 · Product

Active substance: Bisoprolol Fumarate
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 28521
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 10 mg tabletter

PRD1611439 · Product

Active substance: Bisoprolol Fumarate
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 28522
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 5 mg tabletter

PRD1611437 · Product

Active substance: Bisoprolol Fumarate
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 28521
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 2,5 mg tabletter

PRD1611438 · Product

Active substance: Bisoprolol Fumarate
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 28520
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 2,5 mg tabletter

PRD507269 · Product

Active substance: Bisoprolol Fumarate
Substance synonyms: BUT-2-ENEDIOIC ACID: 1-(PROPAN-2-YLAMINO)-3-[4-(2-PROPAN-2-YLOXYETHOXYMETHYL)PHENOXY]PROPAN-2-OL
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 48 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 43904
MA holder: ORION CORPORATION
MA country: Sweden
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 2,5 mg tabletit

PRD507267 · Product

Active substance: Bisoprolol Fumarate
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 28520
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol Orion 10 mg tabletter

PRD507262 · Product

Active substance: Bisoprolol Fumarate
Substance synonyms: BUT-2-ENEDIOIC ACID: 1-(PROPAN-2-YLAMINO)-3-[4-(2-PROPAN-2-YLOXYETHOXYMETHYL)PHENOXY]PROPAN-2-OL
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Week(s)
Authorisation status: Authorised
ATC code: C07AB07 — BISOPROLOL
Marketing authorisation: 43906
MA holder: ORION CORPORATION
MA country: Sweden
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoprololsuccinat "Polpharma", depottabletter

PRD309737 · Product

Active substance: Metoprolol Tartrate
Pharmaceutical form: PROLONGED-RELEASE TABLET
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB02 — METOPROLOL
Marketing authorisation: 41631
MA holder: ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoprololsuccinat "Polpharma", depottabletter

PRD309744 · Product

Active substance: Metoprolol Tartrate
Pharmaceutical form: PROLONGED-RELEASE TABLET
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB02 — METOPROLOL
Marketing authorisation: 41632
MA holder: ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoprololsuccinat "Polpharma", depottabletter

PRD309760 · Product

Active substance: Metoprolol Tartrate
Pharmaceutical form: PROLONGED-RELEASE TABLET
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB02 — METOPROLOL
Marketing authorisation: 41634
MA holder: ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoprololsuccinat "Polpharma", depottabletter

PRD309762 · Product

Active substance: Metoprolol Tartrate
Pharmaceutical form: PROLONGED-RELEASE TABLET
Route of administration: ORAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB02 — METOPROLOL
Marketing authorisation: 41633
MA holder: ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Nebivolol Pliva 5 mg tablete

PRD7928011 · Product

Active substance: Nebivolol Hydrochloride
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AB12 — NEBIVOLOL
Marketing authorisation: HR-H-948491505
MA holder: PLIVA HRVATSKA D.O.O.
MA country: Croatia
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA® 6,25 mg Tabletten

PRD393856 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 57248.01.00
MA holder: STADAPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 25 mg Tabletten

PRD388883 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 1-25398
MA holder: STADA ARZNEIMITTEL GMBH
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA® 12,5 mg Tabletten

PRD393911 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 57248.02.00
MA holder: STADAPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 12,5 mg tabletti

PRD393839 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 16714
MA holder: STADA ARZNEIMITTEL AG
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 6,25 mg töflur.

PRD5832236 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: IS/1/18/015/02
MA holder: STADA ARZNEIMITTEL AG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 6,25 mg Tabletten

PRD393889 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 1-25395
MA holder: STADA ARZNEIMITTEL GMBH
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 12,5 mg töflur

PRD5832260 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: IS/1/18/015/03
MA holder: STADA ARZNEIMITTEL AG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 12,5 mg Tabletten

PRD393848 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 1-25396
MA holder: STADA ARZNEIMITTEL GMBH
MA country: Austria
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 3,125 mg töflur.

PRD5832250 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Week(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: IS/1/18/015/01
MA holder: STADA ARZNEIMITTEL AG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 3,125 mg tabletti

PRD393836 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 16794
MA holder: STADA ARZNEIMITTEL AG
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 25 mg tabletti

PRD393859 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 16715
MA holder: STADA ARZNEIMITTEL AG
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA® 25 mg Tabletten

PRD393873 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 57248.03.00
MA holder: STADAPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 6,25 mg tabletti

PRD393883 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: 16713
MA holder: STADA ARZNEIMITTEL AG
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol STADA 25 mg töflur.

PRD5837359 · Product

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 77 Month(s)
Authorisation status: Authorised
ATC code: C07AG02 — CARVEDILOL
Marketing authorisation: IS/1/18/015/04
MA holder: STADA ARZNEIMITTEL AG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Frederiksberg Hospital

Sponsor organisation: Frederiksberg Hospital
Address: Nordre Fasanvej 57, 1st Floor Entrance 2 1st Floor Entrance 2
City: Frederiksberg
Postcode: 2000
Country: Denmark

Scientific contact point

Organisation: Frederiksberg Hospital
Contact name: Eva Prescott

Public contact point

Organisation: Frederiksberg Hospital
Contact name: Eva Prescott

Locations

1 EU/EEA country · 25 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ended	2,760	25
Rest of world	—	0	—

Investigational sites

Denmark

25 sites · Ended

Region Midtjylland

Dept Cardiology, Hospitalsparken 15, 7400, Herning

Esbjerg Og Grindsted Sygehus

Dept Cardiology, Finsensgade 35, 6700, Esbjerg

Odense University Hospital

Dept Cardiology, Kloevervaenget 47, 5000, Odense C

Odense University Hospital

Medicinsk Afdeling M/FAM, Baagoees Alle 15, 5700, Svendborg

Sygehus Lillebaelt Vejle Sygehus

Department of Cardiology 76362000, Kabbeltoft 25, 7100, Vejle

Copenhagen University Hospital

Dept Cardiology, Kogevej 7, 4000, Roskilde

Copenhagen University Hospital

Dept Cardiology, Ringvej 75, 2730, Herlev

Sygehus Soenderjylland Soenderborg

Afdeling for hjertesygdomme, Kresten Philipsens Vej 15, 6200, Aabenraa

Nordsjaellands Hospital

Dept Cardiology, Dyrehavevej 29, 3400, Hilleroed

Rigshospitalet

Dept Cardiology, Valdemar Hansens Vej 1-23, 2600, Glostrup

Holbaek Sygehus

Department of Cardiology, Smedelundsgade 60, 4300, Holbæk

Lillebaelt Hospital

Dept Cardiology, Sygehusvej 24, 6000, Kolding

Copenhagen University Hospital

Department of Cardiology, Bispebjerg Bakke 23, 2400, Copenhagen Nv

Regionshospital Nordjylland

Dept Cardiology, Bispensgade 37, 9800, Hjoerring

Region Midtjylland

Dept Cardiology, Sundvej 30, 8700, Horsens

Rigshospitalet

Bornholm Hospital, Ullasvej 8, 3700, Roenne

Aalborg University Hospital

Dept Cardiology, Hobrovej 18-22, 9000, Aalborg

Amager Hospital

Dept Cardiology, Italiensvej 1, 2300, Copenhagen S

Region Midtjylland

Dept Cardiology, Heibergs Alle 4, 8800, Viborg

Copenhagen University Hospital

Dept Cardiology, Kogevej 7, 4000, Roskilde

Hvidovre Hospital

Dept Cardiology, Kettegaard Alle 30, 2650, Hvidovre

Næstved Hospital

Dept Cardiology, Ringstedgade 61, 4700, Næstved

Slagelse Hospital

Department of Cardiology 58559000, Ingemannsvej 18, 4200, Slagelse

Gentofte Hospital

Dept Cardiology, Gentofte Hospitalsvej 1, 2900, Hellerup

Aarhus Universitetshospital

Dept Cardiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Denmark	2018-12-01	2025-04-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Title	Submission date	Status	Type
Beta-Blockers after Myocardial Infarction in Patients without Heart Failure SUM-96098	2025-09-02T10:11:42	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
DANBLOCK	2025-09-02T10:11:36	Submitted	Laypersons Summary of Results

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Laypersons summary of results (for publication)	DANBLOCK summary	1
Protocol (for publication)	Protocol	2.1
Recruitment arrangements (for publication)	Recruitment arrangements	1
Subject information and informed consent form (for publication)	Informed consent form	1
Subject information and informed consent form (for publication)	Subject information	1
Summary of Product Characteristics (SmPC) (for publication)	Summary of Product Characteristics (SmPC) - Bisoprolol Orion	1
Summary of Product Characteristics (SmPC) (for publication)	Summary of Product Characteristics (SmPC) - Carvedilol STADA	1
Summary of Product Characteristics (SmPC) (for publication)	Summary of Product Characteristics (SmPC) - Metoprololsuccinat Polpharma	1
Summary of Product Characteristics (SmPC) (for publication)	Summary of Product Characteristics (SmPC) - Nebivolol Pliva	1
Summary of results (for publication)	Article	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-08-02	Denmark	Acceptable 2024-08-21	2024-08-22