Clinical trial • Not applicable • Cardiology

Dabigatran etexilate for Atrial fibrillation | Venous thromboembolism | Frailty

Not applicable trial of Dabigatran etexilate for Atrial fibrillation | Venous thromboembolism | Frailty. Randomised. 2000 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Atrial fibrillation | Venous thromboembolism | Frailty
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-04-2025
First CTIS Authorization Date
28-07-2025

Trial design

Randomised Not applicable trial across 2 sites in Netherlands.

Randomised
Yes
Target Sample Size
2000

Eligibility

Recruits 2000 Participants are frail older adults (aged > 70 years) and the trial marks them as a vulnerable population. Ability to provide informed consent is required; inability to provide informed consent is an exclusion criterion. No provisions for proxy consent or assent are described in the available data..

Vulnerable Population
Participants are frail older adults (aged > 70 years) and the trial marks them as a vulnerable population. Ability to provide informed consent is required; inability to provide informed consent is an exclusion criterion. No provisions for proxy consent or assent are described in the available data.

Inclusion criteria

  • {"criterion_text":"- (a) aged > 70 years\n- (b) using a DOAC (preferably among new users, defined as participants initiating treatment with a DOAC)\n- (c) CFS > 3\n- (d) able to attend to the outpatient clinic (only applicable to community dwelling patients)\n- (e) able to provide informed consent."}

Exclusion criteria

  • {"criterion_text":"- (1) a life expectancy < 3 months\n- (2) not able to provide informed consent."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Our primary end point is the composite outcome of thromboembolic events or bleedings. Bleeding is defined as major bleeding or a clinically relevant non-major (CRNM) bleeding, based on the definition of the International Society on Thrombosis and Haemostasis (ISTH). Thromboembolic events include ischemic stroke, transient ischemic accident (TIA) en peripheral thromboembolism.","definition_or_measurement_approach":"Bleeding defined as major bleeding or clinically relevant non-major (CRNM) bleeding per ISTH definition. Thromboembolic events include ischemic stroke, transient ischemic attack (TIA) and peripheral thromboembolism. The primary endpoint is assessed as a composite incidence of these events."}

Secondary endpoints

  • {"endpoint_text":"- (1) the prevalence of deviant DOAC levels in the frail older population\n- (2) determinants are associated with a deviant DOAC level\n- (3) differences in quality of life between both groups\n- (4) the feasibility/acceptability of the Single Measurement and adjustment strategy via a qualitative study\n- (5) cost-effectiveness of the intervention\n- (6) mortality.","definition_or_measurement_approach":"Endpoints include measurement of DOAC level prevalence (deviant levels), analysis of determinants associated with deviant DOAC levels, assessment of quality of life differences between groups, feasibility/acceptability assessed via a qualitative study, cost-effectiveness analysis, and mortality. Specific measurement instruments/methods are not detailed in the provided JSON (qualitative study and QoL instruments referenced in documents but methods not specified here)."}

Recruitment

Planned Sample Size
2000
Recruitment Window Months
60
Consent Approach
Informed consent must be provided by the participant themselves; inability to provide informed consent is an exclusion criterion. Subject information and informed consent form documents are provided (document identifiers L1_SIS_ICF... exist). Consent materials and public title translations are available in English and Dutch (local/MUMC version present). No description of proxy consent, assent, or additional consent procedures was provided in the JSON.

Geography

Total Number Of Sites
2
Total Number Of Participants
2000

Netherlands

Earliest CTIS Part Ii Submission Date
16-07-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
159
Number Of Sites
2
Number Of Participants
2000

Sites

Site Name
MUMC+
Department Name
Internal Medicine
Principal Investigator Name
Fabienne Magdelijns
Principal Investigator Email
fabienne.magdelijns@mumc.nl
Contact Person Name
Fabienne Magdelijns
Contact Person Email
fabienne.magdelijns@mumc.nl
Site Name
Envida
Department Name
Internal Medicine
Principal Investigator Name
Fabienne Magdelijns
Principal Investigator Email
fabienne.magdelijns@mumc.nl
Contact Person Name
Fabienne Magdelijns
Contact Person Email
fabienne.magdelijns@mumc.nl

Sponsor

Primary sponsor

Full Name
Academisch Ziekenhuis Maastricht
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
DABIGATRAN ETEXILATE
Active Substance
Dabigatran etexilate
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
prodAuthStatus: 2; marketingAuthNumber: -
Maximum Dose
300
Investigational Product Name
APIXABAN
Active Substance
Apixaban
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
prodAuthStatus: 2; marketingAuthNumber: -
Maximum Dose
20 mg
Investigational Product Name
RIVAROXABAN
Active Substance
Rivaroxaban
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus: 2; marketingAuthNumber: -
Maximum Dose
20
Investigational Product Name
EDOXABAN
Active Substance
Edoxaban tosylate monohydrate
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
prodAuthStatus: 2; marketingAuthNumber: -
Maximum Dose
60

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