ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

NCT04912505 | Completed Phase 2

• 1 other identifier: RC31/19/0509
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Purpura, Thrombocytopenic

Keywords

Immune thrombocytopenia; aspirin; pharmacodynamics; proof-of-concept study

Outcome Measures

Primary Outcomes (1)

• Thromboxane B2

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

  24 hours

Study Arms (1)

Single arm

EXPERIMENTAL

Sequential variations of daily aspirin intake time

Drug: Aspirin

Interventions

Aspirin 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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Hemorrhagic Disorders; Autoimmune Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Guillaume MOULIS, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm with sequential variations of daily aspirin intake time

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: January 16, 2023
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)