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

Completed · Phase 2

Conditions studied: Venous Thromboembolism

In brief

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.

Key facts

Study ID

NCT00402467

Run by

Bayer

People needed

613

Starts

2004-02-01

Expected to finish

2004-11-01

Last updated by the study team

2014-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — La Mesa, California, United States
• Study site — Torrance, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Aurora, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Lubbock, Texas, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Red Deer, Alberta, Canada
• Study site — Kelowna, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — Fredericton, New Brunswick, Canada
• Study site — Barrie, Ontario, Canada
• Study site — Greater Sudbury, Ontario, Canada
• Study site — Kitchener, Ontario, Canada
• Study site — Niagara Falls, Ontario, Canada

Full record on ClinicalTrials.gov

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