Multicentre, Prospective Randomized Open Label, Blinded-endpoint (PROBE) Controlled Trial of Early Anticoagulation With Rivaroxaban Versus Standard of Care in Determining Safety at 365 Days in Symptomatic Cerebral Venous Thrombosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 11
- 主要终点
- Composite rate of all-cause mortality, symptomatic intracranial bleeding, major extracranial bleeding
研究概览
简要总结
SECRET examines the safety of rivaroxaban versus standard-of-care for treatment of symptomatic cerebral venous thrombosis, initiated within 14 days of diagnosis.
详细描述
SECRET is an open-label, randomized, controlled, phase II study that will assess the safety of rivaroxaban, a non-vitamin K antagonist oral anticoagulant (NOAC), compared with standard-of-care (unfractionated or low-molecular weight heparin with transition to warfarin [INR 2.0-3.0], or continued low molecular-weight heparin) for cerebral venous thrombosis. Recruitment will occur at 17 high-volume stroke research centres across Canada over 3 years. During the pilot phase, 50 adult patients within 14 days of symptomatic cerebral venous thrombosis diagnosis will be randomized to receive rivaroxaban 20 mg daily versus standard of care (warfarin or low-molecular weight heparin). Patients will be followed for 1 year. The feasibility of recruitment will be tested during the pilot phase and outcomes refined for a future Phase III trial.
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
- Single (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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rivaroxaban
Rivaroxaban
干预措施: Rivaroxaban (Drug)
Standard of care
Unfractionated heparin Low-molecular weight heparin (dalteparin, enoxaparin, tinzaparin) Warfarin
干预措施: Standard of care (Drug)
结局指标
主要结局
Composite rate of all-cause mortality, symptomatic intracranial bleeding, major extracranial bleeding
时间窗: 180 days
Symptomatic intracranial bleeding is defined as a new symptomatic intracranial hemorrhage OR worsening existing intracranial hemorrhage with a \>33% change in hematoma volume, AND either an NIHSS score increase of 4 or more points, or a change in level of consciousness as per NIHSS item 1a, AND the clinical change is thought to be attributable to the hemorrhage. Major extracranial bleeding is defined as bleeding in a critical area or organ, including intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a drop in hemoglobin by 20 g/L or more, leading to transfusion of 2 or more units of whole blood or red cells.
次要结局
- Symptomatic intracranial bleeding(180 days)
- All-cause mortality(180 days)
- Major extracranial bleeding(180 days)
- Recurrent venous thromboembolism(180 days or end of anticoagulation, whichever is sooner)
- Major bleeding or clinically relevant non-major bleeding(180 days or end of anticoagulation, whichever is sooner)
- Partial or complete recanalization(180 or 365 days)
- Functional independence(365 days)
- Reduced functional dependence(365 days)
- Health care resource utilization(365 days)
- Population Health Questionnaire (PHQ)-9 score(365 days)
- EuroQOL 5-Dimensions (EQ-5D) score(365 days)
- Fatigue Assessment score(365 days)
- Headache Impact Test - 6 score(365 days)
- Montreal Cognitive Assessment score(365 days)
- National Institutes of Health toolbox - Cognitive battery score(365 days)
- Boston cookie theft picture description task(365 days)
研究者
Thalia Field
Principal Investigator
University of British Columbia