ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Thromboxane B2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •opposition to participate
- •adults under guardianship or other legal protection
- •deprived of their liberty by judicial or administrative decision
- •pregnancy or breastfeeding
研究组 & 干预措施
Single arm
Sequential variations of daily aspirin intake time
干预措施: Aspirin (Drug)
结局指标
主要结局
Thromboxane B2
时间窗: 24 hours
Platelet production of thromboxane B2 24 hours after a 75 mg aspirin intake
次要结局
未报告次要终点
