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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00402467
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : December 23, 2014
Sponsor:
Information provided by:
Bayer

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Rivaroxaban (BAY59-7939) Drug: Rivaroxaban, (BAY59-7939) Drug: Enoxaparine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : February 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Arm Intervention/treatment
Experimental: Arm 6 Drug: Enoxaparine
30mg bid

Experimental: Arm 1 Drug: Rivaroxaban (BAY59-7939)
2.5mg bid

Experimental: Arm 2 Drug: Rivaroxaban, (BAY59-7939)
5mg bid

Experimental: Arm 3 Drug: Rivaroxaban, (BAY59-7939)
10 mg bid

Experimental: Arm 4 Drug: Rivaroxaban, (BAY59-7939)
20mg bid

Experimental: Arm 5 Drug: Enoxaparine
30mg bid




Primary Outcome Measures :
  1. Composite endpoints of Deep vein Thrombosis (proximal and/or distal),non fatal PE and death from all causes [ Time Frame: 5-9 days after surgery or earlier in case of symptoms indicating deep vein Thrombosis. ]

Secondary Outcome Measures :
  1. Incidence of DVTs (total, proximal, distal) [ Time Frame: Day 6-10 ]
  2. Incidence of symptomatic VTEs [ Time Frame: Day 6-10 ]
  3. The composite endpoint that results from the primary endpoint by substituting VTE related death for all deaths [ Time Frame: Day 6-10 ]
  4. Incidence of symptomatic VTEs (total, PE, DVT) [ Time Frame: Day 6-10 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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)
    • Impaired liver function (transaminases > 2 x ULN)
    • Impaired renal function (serum creatinine > 1.5 x ULN or decreased creatinine clearance < 30ml/min)
    • Active malignant disease
    • Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding
    • Body weight < 45 kg
    • Drug- or alcohol- abuse

Related to current treatment:

  • Therapy with oral anticoagulants (e.g. phenprocoumon, warfarin-sodium, heparins and factor Xa inhibitors other than study medication) and fibrinolytic therapy
  • Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrollment. Patient not able to stop ASA therapy will be excluded
  • All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs will be allowed)
  • Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole). Azole compounds should be stopped at least four days before enrollment

Miscellaneous:

  • Planned intermittent pneumatic compression during active treatment period
  • Planned epidural anaesthesia with indwelling epidural catheter (spinal and epidural anaesthesia without indwelling catheter is allowed)
  • Therapy with another investigational product within 30 days prior to the start of the study
  • Concomitant participation in another trial or study

Removal of Subjects from Study:

A subject who withdraws is one who discontinued a clinical study for any reason.

Subjects may be withdrawn from the study for the following reasons:

  • At their own request or at the request of their legally acceptable representative
  • If, in the investigator's opinion, continuation in the study would be detrimental to the subject's well-being
  • At the specific request of the sponsor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402467


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35205
United States, Arizona
Phoenix, Arizona, United States, 85023
Tucson, Arizona, United States, 85712
United States, California
La Mesa, California, United States, 91942-3019
Torrance, California, United States, 90502-2004
United States, Colorado
Aurora, Colorado, United States, 80011-6798
Aurora, Colorado, United States, 80012
United States, Florida
Jacksonville, Florida, United States, 32216
Palm Beach Gardens, Florida, United States, 33410
Sarasota, Florida, United States, 34239
St. Petersburg, Florida, United States, 33703
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Ohio
Cincinnati, Ohio, United States, 45219
United States, Texas
Dallas, Texas, United States, 75231
Lubbock, Texas, United States, 79410
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Red Deer, Alberta, Canada, T4N 4E7
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 1T2
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, New Brunswick
Fredericton, New Brunswick, Canada, E3B 5N5
Canada, Ontario
Barrie, Ontario, Canada, L4M 6M2
Kitchener, Ontario, Canada, N2G 1G3
Niagara Falls, Ontario, Canada, L2G 5X8
Oshawa, Ontario, Canada, L1G 2B9
Ottawa, Ontario, Canada, K1H 8L6
Peterborough, Ontario, Canada, K9J 7H8
Richmond Hill, Ontario, Canada, L4C 4Z3
St. Catharines, Ontario, Canada, L2R 5K3
Sudbury, Ontario, Canada, P3E 6C3
Thunder Bay, Ontario, Canada, P7B 6V4
Toronto, Ontario, Canada, M3M 2G2
Welland, Ontario, Canada, L3B 4W6
Canada, Prince Edward Island
Charlottetown, Prince Edward Island, Canada, C1A 1L2
Canada, Quebec
Montreal, Quebec, Canada, H3G 1A4
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT00402467    
Other Study ID Numbers: 10945
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Prevention of venous thromboembolism
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents