SLCTR/2022/005招募中4 期
EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation
Hamilton Health Sciences, through its Population Health Research Institute0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age greater than or equal to 45 years, at the time of signing the informed consent
- •Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic intraparenchymal, intraventricular, and/or Convexal subarachnoid hemorrhage cSAH, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy (Table 2)
- •Documented atrial fibrillation (paroxysmal, persistent, permanent)
- •CHA2DS2-VASc score greater than or equal to 2
排除标准
- •Recent intracranial hemorrhage (within 14 days)
- •Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
- •Traumatic or aneurysmal cSAH
- •Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
- •Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
- •Plans for left atrial appendage occlusion
- •Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min)
- •Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
- •Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
- •Chronic use of NSAID
- •Clinically significant active bleeding, including gastrointestinal bleeding
- •Lesions or conditions at increased risk of clinically significant bleeding, e.g. active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis
- •Antiphospholipid antibody syndrome
- •Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- •Known hypersensitivity to edoxaban
- •Estimated inability to adhere to study procedures
- •Pregnancy or breastfeeding
- •Estimated life expectancy < 6 months at the time of enrollment
- •Close affiliation with the investigational site; e.g. a close relative for the investigator, dependent person (e.g., employee or student of the investigational site)
研究者
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