NCT07746882尚未招募3 期
Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy
Second Affiliated Hospital, Zhejiang University, School of Medicine0 个研究点目标入组 680 人开始时间: 2026年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 680
- 主要终点
- 3-month ischemic stroke recurrence
研究概览
简要总结
To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Age ≥18 years
- •Ischemic stroke patients with undetermined etiology, within 14 days of onset, with completed etiological assessment
- •At least one of the following:
- •Cortical or multi-territorial infarct
- •Recurrent stroke or stroke on antiplatelet therapy
- •Left atrial diameter >40 mm
- •Left ventricular dysfunction (EF 30-40% or regional wall motion abnormality)
- •Atrial premature beats >1500/24h
排除标准
- •Stenosis ≥50% in the responsible vessel or high-risk plaque
- •Identified cardioembolic source
- •PFO with planned closure
- •Malignancy
- •Indication for mandatory anticoagulation/antiplatelet therapy
- •Active bleeding (intracranial, subarachnoid, gastrointestinal, etc.)
- •History of intracranial hemorrhage
- •Current or recent gastrointestinal ulcer
- •Recent brain or spinal injury/surgery
- •Known or suspected vascular malformations or aneurysms
- •Severe renal impairment (CrCl <30 ml/min)
- •Liver disease with bleeding risk (Child-Pugh B or C)
- •Pregnancy or lactation
- •Other contraindications to anticoagulation
研究组 & 干预措施
Anti-platelet Group
Other
Aspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable
干预措施: Aspirin (Drug)
Anticoagulation Group
Experimental
Rivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily
干预措施: Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran (Drug)
结局指标
主要结局
3-month ischemic stroke recurrence
时间窗: 90 ± 7 days
Recurrent ischemic stroke within 3 months.
次要结局
- 3-month Composite vascular event(90 ± 7 days)
- Presence of intracerebral hemorrhage (ICH) evaluated by CT or MRI(90 ± 7 days)
- Presence of myocardial infarction within 3 months(90 ± 7 days)
- Presence of major extracranial bleeding within 3 months(90 ± 7 days)
- Presence of vascular death within 3 months(90 ± 7 days)
- 3-month mortality(90 ± 7 days)
研究者
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