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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Sequential variations of daily aspirin intake time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Thromboxane B2 | Platelet production of thromboxane B2 24 hours after a 75 mg aspirin intake | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume MOULIS, MD PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toulouse Hospital | Toulouse | France |
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| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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Single arm with sequential variations of daily aspirin intake time
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|
| D057049 |
| Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |