Clinical trial NCT04912505: ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase
Official title: ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Purpura, Thrombocytopenic
Keywords: Immune thrombocytopenia
aspirin
pharmacodynamics
proof-of-concept study
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm with sequential variations of daily aspirin intake time
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* adult patients
* non-treated immune thrombocytopenia or immune thrombocytopenia 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
* 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

Primary outcomes:
measure: Thromboxane B2
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Guillaume MOULIS, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: