EUCTR2019-002075-33-SK进行中（未招募）1 期
Edoxaban for intracranial hemorrhage survivors with atrial fibrillation - ENRICH-AF: EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation
Hamilton Health Sciences Corporation, through its Population Health Research Institute0 个研究点目标入组 950 人开始时间: 2021年6月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 950
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent provided
- •2.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
- •4.Documented atrial fibrillation (paroxysmal, persistent, permanent)
- •5.CHA2DS2-VASc score =2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 760
排除标准
- •1.Recent intracranial hemorrhage (within 14 days)
- •2.Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
- •3.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
- •4.Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
- •5.Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
- •6.Plans for left atrial appendage occlusion
- •7.Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min)
- •8.Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
- •9.Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
- •10.Chronic use of NSAID
- •11.Clinically significant active bleeding, including gastrointestinal bleeding
- •12.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
- •13.Antiphospholipid antibody syndrome
- •14.Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- •15.Known hypersensitivity to edoxaban
- •16.Estimated inability to adhere to study procedures
- •17.Pregnancy or breastfeeding
- •18.Estimated life expectancy < 6 months at the time of enrollment
- •19.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)
- •20. Lobar intraparenchymal hemorrhage
- •* 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).
研究者
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