ASPIRE: ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04912505

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Purpura, Thrombocytopenic Idiopath Thrombocytopenic Purp Aspirin	Drug: Aspirin	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm with sequential variations of daily aspirin intake timeSingle arm with sequential variations of daily aspirin intake time

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm Sequential variations of daily aspirin intake time	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

Arm

Intervention/Treatment

Experimental: Single arm

Sequential variations of daily aspirin intake time

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

Outcome Measures

Primary Outcome Measures

Thromboxane B2 [24 hours]
Platelet production of thromboxane B2 24 hours after a 75 mg aspirin intake

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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