Clinical trial

ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

Name

RC31/19/0509

Description

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.

Trial arms

Trial start

2023-01-16

Estimated PCD

2025-01-01

Trial end

2025-09-01

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Single arm

Size

Primary endpoint

Thromboxane B2

24 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm with sequential variations of daily aspirin intake time', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

Updated at

2023-07-28

1 organization

1 drug

2 indications

Organization

University Hospital of Toulouse

Drug

Aspirin

Indication

Purpura

Indication

Thrombocytopenia