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Clinical Trials/NCT05773638
NCT05773638
Recruiting
Not Applicable

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

University Hospital, Brest6 sites in 1 country100 target enrollmentDecember 26, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Von Willebrand Diseases
Sponsor
University Hospital, Brest
Enrollment
100
Locations
6
Primary Endpoint
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.
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
December 26, 2021
End Date
December 26, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Von Willebrand disease
  • 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Evaluate the tolerance of these treatments(12 months)
  • Identify potential risk factors(12 months)
  • Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions(12 months)
  • Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants(12 months)
  • Evaluate the effectiveness of these treatments(12 months)

Study Sites (6)

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