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NCT Number: NCT05773638

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, transient ischemic attack, acute coronary syndrome, acute limb ischemia or angina or obliterating arteriopathy of the lower limbs, atrial fibrillation.
  • Have not expressed their opposition

Exclusion criteria

  • - Expression of opposition
  • Acquired von Willebrand syndrome
  • Patients under legal protection
  • Minor

Treatment and study plan

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.

    Time frame: 12 months

    Occurrence of a thromboembolic event validated by an adjudication committee

  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.

    Time frame: 12 months

    Occurrence of a thromboembolic event validated by an adjudication committee

Secondary outcomes

  1. Identify potential risk factors

    Time frame: 12 months

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

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

    Time frame: 12 months

    Prescription of anticoagulant and/or antiaggregant treatment

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

    Time frame: 12 months

    Revascularisation procedure (endovascular or surgical)

  4. Evaluate the tolerance of these treatments

    Time frame: 12 months

    Occurrence of clinical haemorrhage

  5. Evaluate the effectiveness of these treatments

    Time frame: 12 months

    Occurrence of a cardio-embolic event

  6. Evaluate the effectiveness of these treatments

    Time frame: 12 months

    Occurrence of a thromboembolic recurrence

  7. Evaluate the effectiveness of these treatments

    Time frame: 12 months

    Death from haemorrhage and/or thromboembolic causes.

Study contacts

Contact information is provided by the study sponsor or research team.

Brigitte PAN PETESCH

CONTACT

[email protected]

02.98.22.36.50

Sara ROBIN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: TWIGO

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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