Clinical trial NCT05641142: Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
Official title: Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hereditary Hemorrhagic Telangiectasia
Rendu Osler Disease
Keywords: epistaxis
hemorrhage
anticoagulant therapy
antiplatelet therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cohort study
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate in real life, in patients with Hereditary Hemorrhagic Telangiectasia (HHT), the tolerance of the strategy of use of anticoagulant and/or antiplatelet, by comparing a new exposure period (first trimester of treatment) to a period of reference non-exposure (last trimester before start of treatment).

Detailed description: Currently there are no recommendations on the use of anticoagulant and/or antiplatelet treatment in patients with Rendu-Osler Disease.

The main question this study aims to answer is:

• to better determine which anticoagulant and/or antiplatelet therapy are best tolerated or if they are equivalent in Rendu-Osler disease because this type of treatment is often used in urgent and/or vital situations.

Participants will have a 2-year follow-up with biological monitoring of ferritin and hemoglobin level and ESS (Epistaxis Severity Score) and QoL-HHT (Quality of Life Hereditary Hemorrhagic Telangiectasia) questionnaires.

Eligibility criteria: Inclusion Criteria:

* Patient with Rendu-Osler disease with an indication of antiplatelet and/or anticoagulant introduced for less than 3 months (inclusion period within 3 months of exposure)
* Age \> 18 years old
* Patient able to understand and agree to participate in the study
* Affiliation to a social security system

Exclusion Criteria:

* Patient with an indication of antiplatelet and/or anticoagulant but for whom treatment has not been introduced or introduced for more than 3 months
* Refusal to participate
* Pregnant woman or who are breast feeding
* Patients under maintenance of justice, wardship or legal guardianship

Primary outcomes:
measure: Number of transfusions and/or intravenous iron
timeFrame: 3 months after exposure to anticoagulants and/or antiplatelet
Secondary outcomes:
measure: Biological parameters
timeFrame: 3 months after exposure to anticoagulants and/or antiplatelet
measure: Biological parameters
timeFrame: 3 months after exposure to anticoagulants and/or antiplatelet
measure: Bleeding
timeFrame: 3 months after exposure to anticoagulants and/or antiplatelet
measure: Anticoagulant and/or antiplatelet treatment
timeFrame: week 104 after patient inclusion
measure: Thrombotic accident
timeFrame: week 104 after patient inclusion
measure: Epistaxis
timeFrame: week 12, 52 and 104 after patient inclusion
measure: Evaluation of Quality of life
timeFrame: week 6, 12, 52 and 104 after patient inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Caen
country: France
facility: CHU de Caen Normandie
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Hospices Civiles de Lyon
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: AP-HP - Hôpital Ténon
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Vincent GROBOST
role: PRINCIPAL_INVESTIGATOR
References: