An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study
NCT ID: NCT00402467
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
613 participants
INTERVENTIONAL
2004-02-29
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm 6
Enoxaparine
30mg bid
Arm 1
Rivaroxaban (BAY59-7939)
2.5mg bid
Arm 2
Rivaroxaban, (BAY59-7939)
5mg bid
Arm 3
Rivaroxaban, (BAY59-7939)
10 mg bid
Arm 4
Rivaroxaban, (BAY59-7939)
20mg bid
Arm 5
Enoxaparine
30mg bid
Interventions
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Rivaroxaban (BAY59-7939)
2.5mg bid
Rivaroxaban, (BAY59-7939)
5mg bid
Rivaroxaban, (BAY59-7939)
10 mg bid
Rivaroxaban, (BAY59-7939)
20mg bid
Enoxaparine
30mg bid
Enoxaparine
30mg bid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare Pharmaceutical Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
La Mesa, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Jacksonville, Florida, United States
Palm Beach Gardens, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Decatur, Georgia, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Lubbock, Texas, United States
Edmonton, Alberta, Canada
Red Deer, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Fredericton, New Brunswick, Canada
Barrie, Ontario, Canada
Greater Sudbury, Ontario, Canada
Kitchener, Ontario, Canada
Niagara Falls, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Richmond Hill, Ontario, Canada
St. Catharines, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Welland, Ontario, Canada
Charlottetown, Prince Edward Island, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Countries
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Other Identifiers
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10945
Identifier Type: -
Identifier Source: org_study_id