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临床试验/NCT04912505
NCT04912505已完成2 期

ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年1月16日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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