Evaluating Antiplatelet and Anticoagulation Therapy in Hereditary Hemorrhagic Telangiectasia
Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
This study is testing how well people with Hereditary Hemorrhagic Telangiectasia can handle new blood-thinning treatments compared to not using them, to find out which ones work best for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 18 sites (Angers and 17 other locations) |
| Trial ID | NCT05641142 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the tolerance of anticoagulant and/or antiplatelet therapy in patients with Hereditary Hemorrhagic Telangiectasia (HHT) by comparing a new treatment exposure period to a reference non-exposure period. Participants will be monitored over two years, with evaluations including biological monitoring of ferritin and hemoglobin levels, as well as questionnaires assessing epistaxis severity and quality of life. The study seeks to identify which therapies are best tolerated in this patient population, where current treatment guidelines are lacking.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with Rendu-Osler disease who have recently started antiplatelet and/or anticoagulant therapy.
Not a fit: Patients who have not started treatment or have been on treatment for more than three months, as well as pregnant or breastfeeding women, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into effective management strategies for patients with Hereditary Hemorrhagic Telangiectasia, potentially improving their quality of life.
How similar studies have performed: While there is limited guidance on anticoagulant and antiplatelet therapy in Rendu-Osler disease, this study represents a novel approach to understanding treatment tolerance in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 17 other locations
- CHU d'Angers — Angers, France (Not_yet_recruiting)
- CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- Hôpital Ambroise Paré — Boulogne-Billancourt, France (Not_yet_recruiting)
- CHU de Caen Normandie — Caen, France (Not_yet_recruiting)
- CHU clermont-ferrand — Clermont-Ferrand, France (Recruiting)
- CHU de Dijon — Dijon, France (Not_yet_recruiting)
- CHRU de Lille — Lille, France (Not_yet_recruiting)
- Hospices Civiles de Lyon — Lyon, France (Not_yet_recruiting)
- Assistance Publique - Hôpitaux de Marseille — Marseille, France (Not_yet_recruiting)
- CHU de Montpellier — Montpellier, France (Not_yet_recruiting)
- CHU de Nancy — Nancy, France (Not_yet_recruiting)
- CHU de Nantes — Nantes, France (Not_yet_recruiting)
- CHU de Nice — Nice, France (Not_yet_recruiting)
- AP-HP - Hôpital Ténon — Paris, France (Not_yet_recruiting)
- CHU de Poitiers — Poitiers, France (Not_yet_recruiting)
- CHU de Rennes — Rennes, France (Not_yet_recruiting)
- CHRU de Strasbourg — Strasbourg, France (Not_yet_recruiting)
- CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Vincent GROBOST — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.