NCT04912505

ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The incidence of immune thrombocytopenia increases with older age. This population is at risk for arterial thrombosis. Due to an increased turn-over of platelets, low-dose aspirin once daily may be insufficient in this population to protect against arterial thrombosis. This study is aimed at assessing the pharmacodynamics of aspirin once daily on platelet function in these patients.

Detailed description

The incidence of immune thrombocytopenia increases with older age. About 20% of patients who develop immune thrombocytopenia are exposed to low-dose aspirin for arterial thrombosis prophylaxis. Moreover, immune thrombocytopenia patients have an increased risk for developing arterial thrombosis as compared with matched controls from the general population. Because ITP patients have an increased turn-over of platelets and aspirin is an irreversible inhibitor of cyclooxygenase-1, aspirin taken once daily may be insufficient to provide stable inhibition of platelet function. This has been demonstrated in myeloproliferative neoplasms with a higher platelet turn-over as well; aspirin is given twice daily to these patients. In immune thrombocytopenia, epidemiological findings sustain this assumption because aspirin is not associated to an increased risk of bleeding. The primary aim of this study is to assess the residual platelet function after 75 mg aspirin intake (H24). Secondary objectives are to assess the kinetics of platelet function after daily 75 mg aspirin intake and the relation with arterial thrombosis.

Conditions

• Purpura, Thrombocytopenic

Interventions

Type	Name	Description
DRUG	Aspirin	Run-in phase during one week with daily aspirin intake at 8 AM; visit 1: blood sampling at H24 and H2; intermediate phase (two weeks): daily aspirin intake at 8 PM; visit 2: blood sampling at H12; then daily intake of aspirin at the time preferred by the patient and study end visit 2 weeks after visit 2

Timeline

• Start date: 2023-01-16
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2021-06-03
• Last updated: 2025-12-31

Locations

1 site across 1 country: France