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ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

NCT ID: NCT04912505

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2024-01-02

Brief Summary

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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

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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

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Purpura, Thrombocytopenic

Keywords

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Immune thrombocytopenia aspirin pharmacodynamics proof-of-concept study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm with sequential variations of daily aspirin intake time
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm

Sequential variations of daily aspirin intake time

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume MOULIS, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Toulouse Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31/19/0509

Identifier Type: -

Identifier Source: org_study_id