ASPirin in Immune thRombocytopenia patients

Phase 1

Conditions: Immune thrombocytopenia with cardiovascular disease
MedDRA version: 23.0Level: PTClassification code 10083842Term: Immune thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2020-000968-30-FR

Lead Sponsor: CHU 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 and anticoagulant; affiliated or benefiting from public health insurance.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

opposition to participate; modification of ITP treatment, NSAID, serotonin reuptake inhibitor, antiplatelet or anticoagulant drug initiation during the study period; platelet count ?100 x 109/L at visit 1 or 2; CRP>10 mg/L at visit 1 or 2, 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;Timepoint(s) of evaluation of this end point: 2 weeks, 4 weeks and 6 weeks

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; platelet production of TXB2 by lipidomic and platelet function by LTA at H2 and H12 after a75 mg aspirin intake; arterial thromboses identified in the CARMEN registry.;Timepoint(s) of evaluation of this end point: 2 weeks, 4 weeks and 6 weeks