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Completed

NCT Number: NCT00839163

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

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xarelto (Rivaroxaban, BAY59-7939)

Drug

10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

Enoxaparin/Vitamin K-Antagonist

Drug

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

Primary outcomes

  1. Response to treatment as determined by a Complete Compression Ultra sound (CCUS)

    Time frame: 21 days

Secondary outcomes

  1. Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan

    Time frame: Day 21

  2. Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)

    Time frame: Day 84

  3. Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)

    Time frame: Day 1-84

  4. 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

    Time frame: Day 1-84

  5. 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

    Time frame: Day 1-114

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 9, 2009
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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