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CompletedNCT04912505ASPIREUpdated Dec 31, 2025

ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

A Phase 2 interventional study of Aspirin in Purpura, Thrombocytopenic, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by University Hospital, Toulouse · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Purpura, Thrombocytopenic

Keywords

  • Immune thrombocytopenia
  • aspirin
  • pharmacodynamics
  • proof-of-concept study
03

In context

Purpura, Thrombocytopenic

234 studies on the registry are indexed under Purpura, Thrombocytopenic; 26 are open to participants now.

This study's enrollment of 4 is below the median of 50 across 156 interventional studies indexed under Purpura, Thrombocytopenic.

Browse Purpura, Thrombocytopenic studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • opposition to participate
  • adults under guardianship or other legal protection
  • deprived of their liberty by judicial or administrative decision
  • pregnancy or breastfeeding
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Single arm

    Sequential variations of daily aspirin intake time

    Drug: Aspirin

Interventions

  • DrugAspirin

    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

06

What researchers measure

Primary outcomes

  1. Thromboxane B2

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

    Time frame: 24 hours

07

Study locations

1 site
  • Toulouse Hospital
    Toulouse, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04912505
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Jun 3, 2021
Start date
Jan 16, 2023
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024
Last update
Dec 31, 2025

Study contacts

Guillaume MOULIS, MD PhD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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