Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
2,000
Countries
1
Sites
2
Frail older patients with atrial fibrillation or venous thromboembolism
The primary aim of this study is to evaluate the efficacy of a Single Measurement and adjustment strategy based on DOAC levels in the frail older population on the incidence of complications, in particular thromboembolic events or bleedings as composite outcome.
Key facts
- Sponsor
- Academisch Ziekenhuis Maastricht
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 6 Jan 2026 → ongoing
- Decision date (initial)
- 2025-07-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Netherlands Thrombosis Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Dose response, Efficacy
The primary aim of this study is to evaluate the efficacy of a Single Measurement and adjustment strategy based on DOAC levels in the frail older population on the incidence of complications, in particular thromboembolic events or bleedings as composite outcome.
Secondary objectives 1
- Secondary objectives are to evaluate (1) the prevalence of deviant DOAC levels in the frail older population, (2) which determinants are associated with a deviant DOAC level, (3) differences in quality of life between both groups, (4) the feasibility/acceptability of the Single Measurement and adjustment strategy via a qualitative study, (5) cost-effectiveness, and (6) mortality.
Conditions and MedDRA coding
Frail older patients with atrial fibrillation or venous thromboembolism
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: (a) aged > 70 years; (b) using a DOAC (preferably among new users, defined as participants initiating treatment with a DOAC), (c) CFS > 3, (d) able to attend to the outpatient clinic (only applicable to community dwelling patients), and (e) able to provide informed consent.
Exclusion criteria 1
- A potential subject who meets any of the following criteria will be excluded from participation in this study: (1) a life expectancy < 3 months, (2) not able to provide informed consent.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- Our secondary end points are (1) the prevalence of deviant DOAC levels in the frail older population, (2) determinants are associated with a deviant DOAC level, (3) differences in quality of life between both groups, (4) the feasibility/acceptability of the Single Measurement and adjustment strategy via a qualitative study, (5) cost-effectiveness of the intervention, and (6) mortality.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SCP112628460 · ATC
- Active substance
- Apixaban
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20
- Max treatment duration
- 500 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — APIXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100377272 · ATC
- Active substance
- Lactose Monohydrate
- Substance synonyms
- LACTOSE hydrate
- Route of administration
- ORAL
- Max daily dose
- 20
- Max total dose
- 20
- Max treatment duration
- 600 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — RIVAROXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP125068526 · ATC
- Active substance
- Edoxaban Tosylate Monohydrate
- Substance synonyms
- Edoxaban tosilate monohydrate
- Route of administration
- ORAL USE
- Max daily dose
- 60
- Max total dose
- 60
- Max treatment duration
- 500 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — EDOXABAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP115684586 · ATC
- Route of administration
- ORAL USE
- Max daily dose
- 300
- Max total dose
- 300
- Max treatment duration
- 500 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AE07 — DABIGATRAN ETEXILATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Academisch Ziekenhuis Maastricht
- Sponsor organisation
- Academisch Ziekenhuis Maastricht
- Address
- P Debyelaan 25
- City
- Maastricht
- Postcode
- 6229 HX
- Country
- Netherlands
Scientific contact point
- Organisation
- Academisch Ziekenhuis Maastricht
- Contact name
- Fabienne Magdelijns
Public contact point
- Organisation
- Academisch Ziekenhuis Maastricht
- Contact name
- Fabienne Magdelijns
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 2,000 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Envida
Internal Medicine, Abtstraat 2a, 6211LS, Maastricht
Mumc+
Internal Medicine, P.Debeyelaan 25, 6229ET, Maastricht
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 |
|---|---|---|---|---|---|
| Netherlands | 2026-01-06 | 2026-01-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_RESEARCH PROTOCOL EU CT number 2025-521362-10_redacted version | 11 |
| Protocol (for publication) | D4_EU CT number 2025-521362-10_Logboek_CLEAN | 2 |
| Protocol (for publication) | D4_Questionnaire EU CT number 2025-521362-10 CFS_V2_en_Card | 1 |
| Protocol (for publication) | D4_Questionnaire EU CT number 2025-521362-10 Effective_NetherlandsDutchEQ-5D-5LPaperSelf | 1 |
| Protocol (for publication) | D4_Questionnaire EU CT number 2025-521362-10 ISTH-BAT pdf | 1 |
| Protocol (for publication) | D4_Questionnaire EU CT number 2025-521362-10Barthel-index-meetinstr | 1 |
| Protocol (for publication) | D4_Questionnaire EU CT number 2025-521362-10katz-adl | 1 |
| Protocol (for publication) | D4_Questionnaire EU CT number 2025-521362-10LillyPOD_MARS | 1 |
| Protocol (for publication) | D4_Questionnaire EU CT number 2025-521362-10Six-Item Cognitive Impairment Test 6CIT | 1 |
| Protocol (for publication) | D4_Script_FollowUpVisits_EU CT number 2025-521362-10-00_CLEAN | 1 |
| Protocol (for publication) | K5_DSMB_Charter_DOAC-FRAIL_RCT | 1 |
| Recruitment arrangements (for publication) | K1_recruitment_procedure_CLEAN | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EU CT number 2025-521362-10 Patientenfolder | 3 |
| Recruitment arrangements (for publication) | K2_recruitment_material_EU CT number 2025-521362-10 Patientenfolder MUMC | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_EU CT number 2025-521362-10_clean | 9 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_EU CT number 2025-521362-10_MUMC_clean | 9 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Apixaban-epar-product-information_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dabigatran-etexilate-accord-epar-product-information_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Edoxaban-epar-product-information_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Rivaroxaban-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | D1 Synopsis_EU CT number 2025-521362-10_Dutch | 1 |
| Synopsis of the protocol (for publication) | D1 Synopsis_EU CT number 2025-521362-10_English | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-09 | Netherlands | Acceptable with conditions 2025-07-28
|
2025-07-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-08 | Netherlands | Acceptable 2025-12-15
|
2025-12-22 |