CTRI/2020/11/029418招募中3 期
EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation (ENRICH-AF) - ENRICH-AF
Hamilton Health Sciences through its Populatio Health Research Institute0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 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
- •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 intraparenchymal,
- •intraventricular, and/or cSAH, and symptomatic
- •spontaneous or non-penetrating traumatic
- •subdural hemorrhages) on or off antithrombotic
- •therapy, and confirmed to have stabilized on
- •neuroimaging.
- •4. Documented atrial fibrillation (paroxysmal,
- •persistent, permanent)
- •5. CHA2DS2-VASc score >=2
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. Traumatic or aneurysmal cSAH
- •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
- •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)
- •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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