ClinicalTrials.gg
RecruitingNCT05773638TWIGOUpdated Feb 6, 2025

Cardiovascular and Venous Thromboembolism Disease in Patients with Von Willebrand Disease in the French West

An observational study in Von Willebrand Diseases, sponsored by University Hospital, Brest. Recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by University Hospital, Brest · Observational

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in von Willebrand Diseases with a site in France — 5 open to participants now, 6 under way, 1 of them phase 3. von Willebrand Diseases · France.

Planned enrollment
9th of 12
100 · median 168
Started
2021
with 1 other
Observational
12 of 20
2 open now
Registered
19th of 20
by date

Among the 20 studies in von Willebrand Diseases with a site in France, this one is the 9th largest by planned enrollment of the 12 observational ones, is one of 2 that started in 2021, is one of 12 observational ones, and was the 19th registered.

By phase

20 studies; the count open now beside each. This study's row is marked.

Observationalthis study12 · 2 open
Phase 34 · 1 open
No phase3 · 2 open
Phase 11 · 0 open

By the year they started

First in 2012; this study’s year is marked. 2 started in 2021.

Size and results

Median enrollment 36 across the 8 interventional studies, 168 across the 12 observational. Of the 14 that completed or were terminated, 3 (21%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies in von Willebrand Diseases with a site in France, or all of them as a file.
02

Study summary

Due to increasing of life expectancy, patients with von Willebrand disease are exposed to age-related pathologies such as cancer or cardiovascular diseases. Management of thrombotic events is challenging given the inherent bleeding risk in von Willebrand disease. Few data are currently available in the literature.

The aim of the study is to describe the frequency and nature of arterial and venous thromboembolic events and atrial fibrillation in patients with von Willebrand disease in the West of France.

The investigators will perform a retrospective multicenter study conducted in the von Willebrand population of the French West. Von Willebrand adult patients followed in one of the French West medical centers participating in the study, who presented deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, acute coronary syndrome, acute limb ischemia, atrial fibrillation, arteriopathy of the lower limbs, angina will be eligible.

Read the detailed description

Von Willebrand disease is the most common hereditary bleeding disorder. Due to the development of therapies, life expectancy and life quality are increasing in affected patients. However, certain treatments and/or certain comorbidities associated with venous and arterial thrombotic risks may be present in these patients. In the general population, venous thromboembolic disease, arterial thrombosis and atrial fibrillation are frequent. Their management requires the use of antiaggregants and anticoagulant molecules, themselves associated with a bleeding risk. Few data are currently available in the literature concerning the occurrence of venous and arterial thromboembolic events in patients with von Willebrand disease and their management, in the face of a hemorrhagic risk inherent to their pathology and its increase by anti-aggregant treatments and anticoagulants.

The aim of the study is to describe the frequency and nature of arterial and venous thromboembolic events and atrial fibrillation in patients with von Willebrand disease in the West of France.

The investigators will perform a retrospective multicenter study on data conducted in the French West. The study population is composed of patients with von Willebrand disease followed in a reference center in the French West, have consented to be included in the BERHLINGO database (Base d'Etude et de Recherche pour Les INvestigateurs en Hémostase du Grand-Ouest), and who presented deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, acute coronary syndrome, acute limb ischemia, atrial fibrillation, arteriopathy of the lower limbs, angina. Data about von Willebrand disease, risk factors, event, treatment such as antiaggregants and anticoagulants and complications such as hemorrhage or recurrence, will be collected.

03

Conditions studied

  • Von Willebrand Diseases

Keywords

  • von Willebrand disease
  • venous thromboembolism disease
  • cardiovascular disease
  • atrial fibrillation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with von Willebrand disease followed in a reference center in the French West and who have consented to be included in the BERHLINGO database (Base d'Etude et de Recherche pour Les INvestigateurs en Hémostase du Grand-Ouest) with a medical history of deep vein thrombosis, pulmonary embolism, ischemic stroke, transient ischemic attack, acute coronary syndrome, acute limb ischemia, angina, obliterating arteriopathy of the lower limbs or atrial fibrillation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Von Willebrand disease
  • Adult
  • Followed-up in a reference center of West of France (Caen, Brest, Nantes, Rennes, Le Mans, Angers)
  • Consented to be included in BERHLINGO database
  • Have presented a thrombotic and/or embolic event or cardiovascular disease including deep vein thrombosis, pulmonary embolism, ischemic stroke, , acute coronary syndrome, acute limb ischemia or angina or obliterating arteriopathy of the lower limbs, atrial fibrillation.
  • Have not expressed their opposition

Exclusion criteria

Exclusion Criteria:

    • Expression of opposition
  • Acquired von Willebrand syndrome
  • Patients under legal protection
  • Minor
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To describe the frequency of arterial and venous thromboembolic events and cardiac arrhythmia due to atrial fibrillation in patients with Willebrand disease in the Greater West.

    Occurrence of a thromboembolic event validated by an adjudication committee

    Time frame: 12 months

  2. To describe the nature of arterial and venous thromboembolic events and cardiac arrhythmia due to atrial fibrillation in patients with Willebrand disease in the Greater West.

    Occurrence of a thromboembolic event validated by an adjudication committee

    Time frame: 12 months

Secondary outcomes

  1. Identify potential risk factors

    identify whether certain risk factors are more prevalent in the population than others

    Time frame: 12 months

  2. Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions

    Prescription of anticoagulant and/or antiaggregant treatment

    Time frame: 12 months

  3. Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants

    Revascularisation procedure (endovascular or surgical)

    Time frame: 12 months

  4. Evaluate the tolerance of these treatments

    Occurrence of clinical haemorrhage

    Time frame: 12 months

  5. Evaluate the effectiveness of these treatments

    Occurrence of a cardio-embolic event

    Time frame: 12 months

  6. Evaluate the effectiveness of these treatments

    Occurrence of a thromboembolic recurrence

    Time frame: 12 months

  7. Evaluate the effectiveness of these treatments

    Death from haemorrhage and/or thromboembolic causes.

    Time frame: 12 months

07

Study locations

1 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

Time frame: Data will be available beginning three month and ending five years following the publication

Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2021 (actual). Primary completion is estimated for Dec 2026, 60 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2023
First posted
Mar 17, 2023
StartActual
Dec 26, 2021
Primary completionEst.
Dec 26, 2026
CompletionEst.
Dec 26, 2026
Last update
Feb 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05773638
Responsible party
Sponsor
First posted
Mar 17, 2023
Start date
Dec 26, 2021
Primary completion
Dec 26, 2026 (estimated)
Completion
Dec 26, 2026 (estimated)
Last update
Feb 6, 2025

Study contacts

Brigitte PAN PETESCH
Contact
brigitte.pan-petesch@chu-brest.fr
02.98.22.36.50
Sara ROBIN
Contact
sara.robin@chu-brest.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion