临床试验/NCT01516814

NCT01516814已完成3 期

Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis

Bayer0 个研究点目标入组 40 人开始时间: 2012年2月最近更新: 2017年1月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Bayer
入组人数: 40
主要终点: Number of participants with newly onset of symptomatic venous thromboembolism (VTE)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.

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: None

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men and women >/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)

排除标准

•Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
•More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of PE to randomization
•Calculated creatinine clearance (CLCR) < 30 mL/min
•Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
•Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
•Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg

研究组 & 干预措施

Arm 1

Experimental

干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)

Arm 2

Active Comparator

干预措施: Unfractionated heparin (Drug)

Arm 3

Active Comparator

干预措施: Warfarin (Drug)

结局指标

主要结局

Number of participants with newly onset of symptomatic venous thromboembolism (VTE)

时间窗: Up to 12 months

Number of clinically relevant bleedings

时间窗: Up to 2 days after last dose

次要结局

Number of participants with improvement in thrombotic burden(At week 3)
Number of participants with deterioration in thrombotic burden(Up to 12 months)
Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus(Up to 12 months)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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