Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients

Phase 3

Completed

• Conditions: Pulmonary Embolism
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Warfarin; Drug: Unfractionated heparin

• Registration Number: NCT01516814
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Study Start: 2012-02
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Rivaroxaban (Xarelto, BAY59-7939)	-
Arm 3	Warfarin	-
Arm 2	Unfractionated heparin	-

Primary Outcome Measures

Name	Time	Method
Number of participants with newly onset of symptomatic venous thromboembolism (VTE)	Up to 12 months
Number of clinically relevant bleedings	Up to 2 days after last dose

Secondary Outcome Measures

Name	Time	Method
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