Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

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

Detailed Description
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The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded.

Official Title
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Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Unfractionated heparin
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) Exclusion Criteria: Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT 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 DVT 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* 10 mg twice daily for 21 days, followed by 15 mg once daily<br>|
| Experimental: Arm 2<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* 15 mg twice daily for 21 days, followed by 15 mg once daily<br>|
| Active Comparator: Arm 3<br> | Drug: Unfractionated heparin<br>* To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)<br>|
| Active Comparator: Arm 4<br> | Drug: Warfarin<br>* To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute symptomatic deep vein thrombosis