An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study

NCT00402467 | Completed Phase 2 DMC

• 1 other identifier: 10945
• Study Type: interventional
• Target: 613
• Locations: 2 countries
• Sites: 36

Brief Summary

The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells). It is available as a tablet. 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. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously. In this study 4 different doses of the investigational drug BAY59-7939 will be tested in comparison to Enoxaparin. You will receive during the study either one of the following BAY59-7939 treatments or Enoxaparin. The following doses of BAY59-7939 will be tested: Dose I ; Dose II, Dose III, Dose IV. This study will run for approximately 7 months in a number of countries. In total, up to 600 patients may participate in this study.

Conditions

Venous Thromboembolism

Keywords

Prevention of venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• Composite endpoints of Deep vein Thrombosis (proximal and/or distal),non fatal PE and death from all causes

  5-9 days after surgery or earlier in case of symptoms indicating deep vein Thrombosis.

Secondary Outcomes (4)

• Incidence of DVTs (total, proximal, distal)

  Day 6-10

• Incidence of symptomatic VTEs

  Day 6-10

• The composite endpoint that results from the primary endpoint by substituting VTE related death for all deaths

  Day 6-10

• Incidence of symptomatic VTEs (total, PE, DVT)

  Day 6-10

Study Arms (6)

Arm 6

EXPERIMENTAL

Drug: Enoxaparine

Arm 1

EXPERIMENTAL

Drug: Rivaroxaban (BAY59-7939)

Arm 2

EXPERIMENTAL

Drug: Rivaroxaban, (BAY59-7939)

Arm 3

EXPERIMENTAL

Drug: Rivaroxaban, (BAY59-7939)

Arm 4

EXPERIMENTAL

Drug: Rivaroxaban, (BAY59-7939)

Arm 5

EXPERIMENTAL

Drug: Enoxaparine

Interventions

Rivaroxaban, (BAY59-7939) DRUG

5mg bid

Arm 2

Enoxaparine DRUG

30mg bid

Arm 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects aged 18 years or above and postmenopausal female subjects
• Subjects scheduled for elective total knee replacement
• Subjects written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures

You may not qualify if:

• Related to medical history:
• Any prior DVT or PE
• Myocardial infarction (MI), TIA or ischaemic stroke within the last 6 months prior to randomization
• History of heparin-induced thrombocytopenia, allergy to heparins
• Intracerebral or intraocular bleeding within the last 6 months prior to randomization
• History of gastrointestinal disease (e.g. active peptic ulcer) with gastrointestinal bleeding within the last 6 months prior to randomization
• History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug (e.g. severe active inflammatory bowel disease, short gut syndrome)
• Amputation of one leg
• Related to current symptoms or findings:
• Heart insufficiency NYHA III-IV
• Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits)including patients with acquired or congenital thrombophilia
• Thrombocytopenia (platelets \< 100,000/µl)
• Macroscopic haematuria
• Allergy to contrast media
• Severe hypertension (SBP \> 200mmHg, DBP \> 100 mmHg)

Sponsors & Collaborators

• Bayer: lead

Study Sites (36)

Unknown Facility

Birmingham, Alabama, 35205, United States

Location

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Phoenix, Arizona, 85023, United States

Location

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Tucson, Arizona, 85712, United States

Location

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La Mesa, California, 91942-3019, United States

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Torrance, California, 90502-2004, United States

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Aurora, Colorado, 80011-6798, United States

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Aurora, Colorado, 80012, United States

Location

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Jacksonville, Florida, 32216, United States

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Palm Beach Gardens, Florida, 33410, United States

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Sarasota, Florida, 34239, United States

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St. Petersburg, Florida, 33703, United States

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Decatur, Georgia, 30033, United States

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Cincinnati, Ohio, 45219, United States

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Dallas, Texas, 75231, United States

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Lubbock, Texas, 79410, United States

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Edmonton, Alberta, T6G 2B7, Canada

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Red Deer, Alberta, T4N 4E7, Canada

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Kelowna, British Columbia, V1Y 1T2, Canada

Location

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Fredericton, New Brunswick, E3B 5N5, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Greater Sudbury, Ontario, P3E 6C3, Canada

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Kitchener, Ontario, N2G 1G3, Canada

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Niagara Falls, Ontario, L2G 5X8, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Peterborough, Ontario, K9J 7H8, Canada

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Richmond Hill, Ontario, L4C 4Z3, Canada

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St. Catharines, Ontario, L2R 5K3, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Toronto, Ontario, M3M 2G2, Canada

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Welland, Ontario, L3B 4W6, Canada

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Charlottetown, Prince Edward Island, C1A 1L2, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Québec, Quebec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 22, 2006
• Study Start: February 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (15); CA (21)