Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

Official Title
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ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.

Conditions
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Venous Thrombosis, Deep Vein Thrombosis

Intervention / Treatment
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* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Enoxaparin/Vitamin K-Antagonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with acute symptomatic proximal deep vein thrombosis Exclusion Criteria: Contraindication to comparator drugs Symptomatic Pulmonary embolism Conditions with increased bleeding risk Unstable patients with reduced life expectancy Severe renal impairment Impaired liver function Strong CYP 3A4 inhibitors Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics NSAIDs with half-life > 17 hours

Ages Eligible for Study
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Minimum Age: 18 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: Xarelto (Rivaroxaban, BAY59-7939)<br>* 10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).<br>|
| Experimental: Arm 2<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).<br>|
| Experimental: Arm 3<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).<br>|
| Experimental: Arm 4<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).<br>|
| Active Comparator: Arm 5<br> | Drug: Enoxaparin/Vitamin K-Antagonist<br>* Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment as determined by a Complete Compression Ultra sound (CCUS) |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan |  | Day 21 | 
| Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS) |  | Day 84 | 
| Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT) |  | Day 1-84 | 
| Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period |  | Day 1-84 | 
| Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug |  | Day 1-114 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embolism and Thrombosis, Pulmonary embolism, Embolism, Thrombosis