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NCT Number: NCT05641142

Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

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).

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Key information

Conditions

Hereditary Hemorrhagic Telangiectasia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epistaxis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rendu Osler Disease Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease

Other

Monitoring:

  • hemoglobin and ferritin levels
  • transfusion or intravenous iron
  • hospitalization for bleeding or thrombose
  • digestive bleeding and/or another haemorrhagic accident
  • severity of epistaxis
  • quality of life

Primary outcomes

  1. Number of transfusions and/or intravenous iron

    Time frame: 3 months after exposure to anticoagulants and/or antiplatelet

    Number of transfusions and/or intravenous iron before (3 months) and within 3 months after exposure to anticoagulants and/or antiplatelet in patients with Rendu-Osler disease.

Secondary outcomes

  1. Biological parameters

    Time frame: 3 months after exposure to anticoagulants and/or antiplatelet

    Evolution of ferritin levels.

  2. Biological parameters

    Time frame: 3 months after exposure to anticoagulants and/or antiplatelet

    Evolution of hemoglobin levels.

  3. Bleeding

    Time frame: 3 months after exposure to anticoagulants and/or antiplatelet

    Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage.

  4. Anticoagulant and/or antiplatelet treatment

    Time frame: week 104 after patient inclusion

    Frequency of continuation and/or modification and/or cessation of treatment if indication maintained.

  5. Thrombotic accident

    Time frame: week 104 after patient inclusion

    Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death

  6. Epistaxis

    Time frame: week 12, 52 and 104 after patient inclusion

    Evolution of epistaxis severity via ESS score

  7. Evaluation of Quality of life

    Time frame: week 6, 12, 52 and 104 after patient inclusion

    Quality of life assessment via QoL-HHT questionnaire

Study contacts

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

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: PROPLACO-Tel

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Dec 7, 2022
Registry last updated
Jul 10, 2026

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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