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)
10
Enrollment
1
Arm
16
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

  1. 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:
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:
  • opposition to participate

  • adults under guardianship or other legal protection

  • deprived of their liberty by judicial or administrative decision

  • pregnancy or breastfeeding

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Guillaume MOULIS, MD PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04912505
Other Study ID Numbers:
  • RC31/19/0509
First Posted:
Jun 3, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022