2024-518508-31-00招募中4 期
EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation
Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International65 个研究点 分布在 7 个国家目标入组 380 人开始时间: 2024年12月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 380
- 试验地点
- 65
- 主要终点
- The primary efficacy end point is composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism.
研究概览
简要总结
To assess whether edoxaban (60/30 mg daily) compared to nonanticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc score =/>2) participants with previous intracranial hemorrhage.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •1.Written informed consent provided
- •Age ≥45 years, at the time of signing the informed consent
- •3.Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic non-lobar intraparenchymal or intraventricular hemorrhage, and symptomatic spontaneous or non- penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy (Table 2)
- •4.Documented atrial fibrillation (paroxysmal, persistent, permanent)
- •5.CHA2DS2-VASc score ≥2
排除标准
- •Recent intracranial hemorrhage (within 14 days)
- •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)
- •Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non- penetrating traumatic subdural hemorrhages)
- •Lobar intraparenchymal hemorrhages
- •Post menopausal female subjects must be amenorrheic for ≥12 months prior to screening or ≥6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to screening. Women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization or urine pregnancy testing within 24 hours of randomization. Heterosexually active women of childbearing potential must use highly effective methods of contraception for 32 days after discontinuation (duration of study drug plus 30 days duration of one ovulatory cycle).
- •Isolated subarachnoid hemorrhage (convexity or basal); subarachnoid blood tracking onto convexity secondary to an intraventricular hemorrhage or as part of a multicompartment bleed in cases of traumatic subdural hemorrhages are eligible
- •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)
结局指标
主要结局
The primary efficacy end point is composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism.
The primary efficacy end point is composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism.
The primary safety endpoint is major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
The primary safety endpoint is major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
次要结局
- Ischemic stroke
- Cardiovascular death
- Hemorrhagic stroke
- Disabling/fatal stroke
- Systemic embolism
- Composite of all stroke, myocardial infarction, systemic embolism or all cause death
- Net clinical benefit (composite of stroke, systemic embolism, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area)
- Modified Rankin scale (mRS) at 12 months
- The secondary safety end point(s) are: All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage)
- Fatal intracranial hemorrhage
- Subdural hemorrhage
- Hospitalization for any cause
研究者
Dr. Ashkan Shoamanesh
Scientific
Hamilton Health Sciences Corporation
研究点 (65)
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