NCT03091621Unknown不适用
Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Recurrence/exacerbation of symptomatic venous thromboembolism (VTE)
研究概览
简要总结
To clarify the effectiveness and safety of the direct factor Xa inhibitor rivaroxaban in domestic clinical use for patients with deep vein thrombosis and pulmonary embolism
详细描述
Research design: multicenter collaboration, prospective, non-interventional, observational research
Research outline:
Registration period: Dec 2016 (after ethics committee approval) to May 2018 (1 year and 6 months) Investigation period: Dec 2016 (after ethics committee approval) to Nov 2019 (At least 1 year and 6 months) Target number of participants: 1,000 participants Estimated number of participating institutions: 150 medical institutions Research secretariat: Mebix, Inc.
Research procedure:
- Perform patient registration within 3 weeks of first prescription
- Also record when the drug was discontinued for any reason, such as an event or bleeding etc, between the time of first prescription and registration
- Track progress as much as possible until the end of the study period, regardless of continuation or discontinuation of study drug administration, and also in cases where there is manifestation of efficacy or safety events
- Track progress of all cases as much as possible until the end of the study period, regardless of continuation, discontinuation or termination of study drug administration. Patients transferred to the hospital are managed in the same way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban
排除标准
- •Contraindication to rivaroxaban
- •Chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis)
- •Active bleeding
- •Patients determined to be inappropriate for the study by the attending doctor
结局指标
主要结局
Recurrence/exacerbation of symptomatic venous thromboembolism (VTE)
时间窗: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
次要结局
- Major bleeding event (ISTH bleeding criteria)(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Non-major bleeding event (bleeding events that do not correspond to major bleeding)(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Bleeding event during the initial strengthening treatment period(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Acute coronary syndrome(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Comparison of examples of treatment continuation/discontinuation events(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Serious adverse events(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Cardiovascular death(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- All deaths(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Relationship between change in D-dimer and recurrence(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Onset/exacerbation of symptomatic pulmonary embolism (PE)(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Onset/exacerbation of symptomatic deep vein thrombosis (DVT)(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Recurrence/exacerbation of symptomatic venous thromboembolism during the initial strengthening treatment period(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- VTE related death(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
- Cerebral infarction(From the time of research participation to 30th November 2019 (At least 1 year and 6 months))
研究者
Atsushi Hirayama
Principal Investigator, Nihon University School of Medicine Division of Cardiology, Department of Internal Medicine
Nihon University
研究点 (1)
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