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临床试验/NCT05032053
NCT05032053招募中不适用

Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

Xijing Hospital23 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
23
主要终点
Increase of cerebral microbleeds

研究概览

简要总结

To observe the effect of different antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds. And further combined with proteomic methods to explore serological markers that can be used to accurately predict the prognosis of such patients.

详细描述

Cerebral microbleeds (CMBs) are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Antithrombotic drug are widely used in the secondary prevention of patients with ischemic stroke. Studies have shown that antithrombotic drug can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe antithrombotic therapy is still unclear.

We will study from two aspects: 1) We designed a cohort registration study to observe the prognosis and progress of CMBs in ischemic stroke patients one year after using various antithrombotic drugs. 2) Data independent acquisition quantitative proteomics (DIA quantitative proteomics) will be used to screen serum protein markers that may affect the prognosis of ischemic stroke patients with CMBs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed clinically as ischemic stroke;
  • Age ≥ 40 years;
  • Onset time ≤ 3 months;
  • Informed consent was signed.

排除标准

  • Patients with symptomatic intracranial hemorrhage;
  • bleeding lesion > 10 mm was found on SWI;
  • Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
  • There are contraindications for antithrombotic drugs use;
  • Serious systemic diseases;
  • Refusal to sign informed consent or poor compliance.

结局指标

主要结局

Increase of cerebral microbleeds

时间窗: 1 year after onset

How many cerebral microbleeds increased after 1 year of antithrombotic drugs treatment. The number of microbleeds will be detected by MR-SWI.

次要结局

  • Stroke recurrence rate(1 year after onset)
  • The incidence of cerebral hemorrhage(1 year after onset)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (23)

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