ASPirin in Immune thRombocytopenia patients

ASPirin in Immune thRombocytopenia patients with cardiovascular disEase - ASPIRE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000968-30-FR

Enrollment

Registered

2021-03-02

Start date

2021-04-13

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune thrombocytopenia with cardiovascular disease MedDRA version: 23.0 Level: PT Classification code 10083842 Term: Immune thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: Kardégic Product Name: acide acétylsalicylique Pharmaceutical Form: Oral solution in sachet

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

France

Contacts

Public ContactCLINICAL RESEARCH ASSISTANT

CHU Toulouse

daguzan.c@chu-toulouse.fr561778490+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026