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ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04912505
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : July 28, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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 disease Intervention/treatment Phase
Purpura, Thrombocytopenic Drug: Aspirin 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single 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
Actual Study Start Date : January 16, 2023
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/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
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Primary Outcome Measures :
  1. Thromboxane B2 [ Time Frame: 24 hours ]
    Platelet production of thromboxane B2 24 hours after a 75 mg aspirin intake


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04912505


Contacts
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Contact: Guillaume MOULIS, MD PhD 05 61 77 58 94 ext 33 moulis.g@chu-toulouse.fr

Locations
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France
Toulouse Hospital Recruiting
Toulouse, France
Contact: Guillaume MOULIS, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Guillaume MOULIS, MD PhD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04912505    
Other Study ID Numbers: RC31/19/0509
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Immune thrombocytopenia
aspirin
pharmacodynamics
proof-of-concept study
Additional relevant MeSH terms:
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Cardiovascular Diseases
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Platelet Disorders
Hematologic Diseases
Cytopenia
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
 Immune System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors