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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis; Deep Vein Thrombosis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2217
  • South Australia
    • Adelaide, South Australia, Australia, 5042
    • Adelaide, South Australia, Australia, 5011
  • Victoria
    • Melbourne, Victoria, Australia, 3135
    • Melbourne, Victoria, Australia, 3128
    • Melbourne, Victoria, Australia, 3181
  • Western Australia
    • Perth, Western Australia, Australia, 6000
• Austria
  • Wien, Austria, 1090
  • Wien, Austria, 1171
  • Steiermark
    • Graz, Steiermark, Austria, 8036
• Belgium
  • Duffel, Belgium, 2570
  • Leuven, Belgium, 3000
• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04544 000
    • São Paulo, SP, Brazil, 01323-001
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
    • Hamilton, Ontario, Canada, L8N 4A6
    • North Bay, Ontario, Canada, P1B 5A4
    • Oshawa, Ontario, Canada, L1G 2B9
    • Ottawa, Ontario, Canada, K1Y 4E9
    • Sudbury, Ontario, Canada, P3E 3B5
    • Toronto, Ontario, Canada, M3N 1N1
    • Windsor, Ontario, Canada, N8X 3V6
  • Quebec
    • Montreal, Quebec, Canada, H3T 1M5
    • Montreal, Quebec, Canada, H2W 1T8
• Colombia
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Medellín, Colombia
• Czechia
  • Brno, Czechia, 656 91
  • Kladno, Czechia, 27259
  • Ostrava, Czechia, 728 80
  • Plzen, Czechia, 30599
  • Praha 10, Czechia, 10034
  • Praha 2, Czechia, 12808
  • Praha 6, Czechia, 169 02
• Germany
  • Berlin, Germany, 10787
  • Berlin, Germany, 10365
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69115
    • Karlsbad, Baden-Württemberg, Germany, 76307
    • Mannheim, Baden-Württemberg, Germany, 68167
  • Bayern
    • München, Bayern, Germany, 80336
  • Hessen
    • Darmstadt, Hessen, Germany, 64276
  • Nordrhein-Westfalen
    • Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51429
    • Paderborn, Nordrhein-Westfalen, Germany, 33098
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
• Hungary
  • Budapest, Hungary, 1115
  • Debrecen, Hungary, 4032
  • Pecs, Hungary, 7624
  • Szentes, Hungary, 6600
• Israel
  • Afula, Israel, 18101
  • Ashkelon, Israel, 78306
  • Haifa, Israel, 31096
  • Holon, Israel, 58100
  • Jerusalem, Israel, 91120
  • Kfar Saba, Israel, 44281
  • Tel Aviv, Israel, 64239
• Italy
  • Bologna, Italy, 40138
  • Milano, Italy, 20162
  • Milano, Italy, 20142
  • Padova, Italy, 35128
  • Palermo, Italy, 90129
  • Perugia, Italy, 06122
  • Piacenza, Italy, 29100
  • Reggio Emilia, Italy, 42100
  • Varese, Italy, 21100
  • Milano
    • Rozzano, Milano, Italy, 20089
• Netherlands
  • Arnhem, Netherlands, 6815 AD
  • Den Bosch, Netherlands, 5211 RB
  • Den Haag, Netherlands, 2512 VA
  • Dirksland, Netherlands, 3247 BW
  • Enschede, Netherlands, 7511 JX
  • Leidschendam, Netherlands, 2262 BA
  • Rotterdam, Netherlands, 3083 AN
• New Zealand
  • Auckland, New Zealand, 1023
  • Auckland, New Zealand, 0622
  • Christchurch, New Zealand, 8011
• Peru
  • Lima, Peru, 01
  • Lima, Peru, 31
  • Lima Cercado, Peru, LIMA 1
• Poland
  • Bialystok, Poland, 15-276
  • Bytom, Poland, 41-902
  • Gdansk, Poland, 80-952
  • Katowice, Poland, 40-752
  • Lublin, Poland, 20-718
  • Olsztyn, Poland, 10-560
  • Poznan, Poland, 61-833
  • Warszawa, Poland, 02-097
• South Africa
  • Freestate
    • Bloemfontein, Freestate, South Africa, 9300
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0084
    • Pretoria, Gauteng, South Africa, 0157
    • Pretoria, Gauteng, South Africa, PRETORIA
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7531
    • Somerset West, Western Cape, South Africa, 7130
• Spain
  • Barcelona, Spain, 08036
  • Girona, Spain, 17007
  • Madrid, Spain, 28006
  • Madrid, Spain, 28007
  • Valencia, Spain, 46010
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
  • Girona
    • Olot, Girona, Spain, 17800
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
• Sweden
  • Göteborg, Sweden, 416 85
  • Göteborg, Sweden, 413 45
  • Halmstad, Sweden, 301 85
  • Jönköping, Sweden, 551 85
  • Lund, Sweden, 221 85
• Switzerland
  • Basel, Switzerland, 4031
  • Bern, Switzerland, 3010
  • Luzern, Switzerland, 6000
  • Zürich, Switzerland, 8091

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Xarelto (Rivaroxaban, BAY59-7939); 10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Experimental: Arm 2	Drug: Xarelto (Rivaroxaban, BAY59-7939); 10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Experimental: Arm 3	Drug: Xarelto (Rivaroxaban, BAY59-7939); 10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Experimental: Arm 4	Drug: Xarelto (Rivaroxaban, BAY59-7939); 10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).; Drug: Xarelto (Rivaroxaban, BAY59-7939); 40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Active Comparator: Arm 5	Drug: Enoxaparin/Vitamin K-Antagonist; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (Estimated): February 9, 2009

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Embolism; Thrombosis; Pulmonary embolism; Embolism and Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Micronutrients; Vitamins; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Rivaroxaban; Enoxaparin
• Other Study ID Numbers: 11223 (FUNDESALUD); 2004-001083-43 (EudraCT Number); ODIXa-DVT (Other Identifier: Company Internal)