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 sites40 target enrollmentFebruary 2012

ConditionsPulmonary Embolism

InterventionsRivaroxaban (Xarelto, BAY59-7939)Unfractionated heparin Warfarin

DrugsRivaroxaban (Xarelto, BAY59-7939)Unfractionated heparin Warfarin

Overview

Phase: Phase 3
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Conditions: Pulmonary Embolism
Sponsor: Bayer
Enrollment: 40
Primary Endpoint: Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

November 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Arm 1

Intervention: Rivaroxaban (Xarelto, BAY59-7939)

Arm 2

Intervention: Unfractionated heparin

Arm 3

Intervention: Warfarin

Outcomes

Primary Outcomes

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

Time Frame: Up to 12 months

Number of clinically relevant bleedings

Time Frame: Up to 2 days after last dose

Secondary Outcomes

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)