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

Von Willebrand Diseases Clinical Trial

— TWIGO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05773638
• Other study ID #: TWIGO ( 29BRC21.0204)
• Status: Active, not recruiting
• Start date: December 26, 2021
• Est. completion date: December 26, 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Von Willebrand Diseases

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Brest	Brest
France	CHU de Caen	Caen
France	CH le MANS	Le Mans
France	CHU de Nantes	Nantes
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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	12 months
Secondary	Identify potential risk factors	identify whether certain risk factors are more prevalent in the population than others	12 months
Secondary	Number of revascularisation procedures, anticoagulants and antiaggregants prescribed for these conditions	Prescription of anticoagulant and/or antiaggregant treatment	12 months
Secondary	Evaluate the nature of treatments prescribed for these pathologies: revascularisation procedures, anticoagulants and antiaggregants	Revascularisation procedure (endovascular or surgical)	12 months
Secondary	Evaluate the tolerance of these treatments	Occurrence of clinical haemorrhage	12 months
Secondary	Evaluate the effectiveness of these treatments	Occurrence of a cardio-embolic event	12 months
Secondary	Evaluate the effectiveness of these treatments	Occurrence of a thromboembolic recurrence	12 months
Secondary	Evaluate the effectiveness of these treatments	Death from haemorrhage and/or thromboembolic causes.	12 months