Aspirin in immune thrombocytopenia patients with cardiovascular disease
Phase 1
- Conditions
- Immune thRombocytopeniaTherapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2024-513846-13-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
adult patients (sup 18-year-old), non-treated ITP or ITP with stable treatment (at least 1 month), treated with aspirin daily for a cardiovascular disease, stable platelet count < 100 x 109/L, at least one month following an arterial thrombosis; no other antiplatelet drug, female patient with childbearing potential must have acceptable method of birth control, affiliated or benefiting from public health insurance.
Exclusion Criteria
opposition to participate, adults Under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision, pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the residual platelet function after 75 mg aspirin intake (H24);Secondary Objective: To assess the kinetics of platelet function after daily 75 mg aspirin intake and the relation with arterial thrombosis;Primary end point(s): Platelet production of thromboxane B2 (TXB2) 24 hours after a 75 mg aspirin intake
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Platelet function by light transmission agregometry (LTA) 24 four hours after a 75 mg aspirin intake;;Secondary end point(s):platelet production of TXB2 by lipidomic and platelet function by LTA at H2 and H12 after a75 mg aspirin intake;Secondary end point(s):arterial thromboses identified in the CARMEN registry.;Secondary end point(s):Measurement of platelet TXB2 synthesis after platelet stimulation by arachidonic acid at H2 and H12 from a dose of 75 mg of AAS. 12-HETE produced by lymphoxygenase and quantified in the same mass spectrometry profile as TXB2 will also be taken into account.