check_circleStudy Completed

Venous Thromboembolism

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

Trial purpose

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 Participants Requirements

Sex

Both

Age

18 Years
  • - 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


  • 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

Trial summary

Enrollment Goal
613
Trial Dates
February 2004 - November 2004
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Birmingham, 35205, United States
Completed
Welland, L3B 4W6, Canada
Completed
Phoenix, 85023, United States
Completed
Red Deer, T4N 6V7, Canada
Completed
Sudbury, P3E 6C3, Canada
Completed
Sarasota, 34239, United States
Completed
Winnipeg, R3A 1M3, Canada
Completed
Lubbock, 79410, United States
Completed
Quebec, G1J 1Z4, Canada
Completed
Decatur, 30033, United States
Completed
Ottawa, K1H 8L6, Canada
Completed
Cincinnati, 45219, United States
Completed
Montreal, H3G 1A4, Canada
Completed
Aurora, 80011-6798, United States
Completed
St. Catherines, L2R 5K3, Canada
Completed
Kelowna, V1Y 1T2, Canada
Completed
Vancouver, V6Z 1Y6, Canada
Completed
Toronto, M3M 2G2, Canada
Completed
St. Petersburg, 33703, United States
Completed
Barrie, L4M 6M2, Canada
Completed
Charlottetown, C1A 1L2, Canada
Completed
Richmond Hill, L4C 4Z3, Canada
Completed
La Mesa, 91942, United States
Completed
Palm Beach Gardens, 33410, United States
Completed
Torrance, 90502-2004, United States
Completed
Oshawa, L1G 2B9, Canada
Completed
Peterborough, K9J 7H8, Canada
Completed
Tucson, 85712, United States
Completed
Jacksonville, 32216, United States
Completed
Niagara Falls, L2G 5X8, Canada
Completed
Dallas, 75231, United States
Completed
Aurora, 80012, United States
Completed
Edmonton, T6G 2B7, Canada
Completed
Thunder Bay, P7B 6V4, Canada
Completed
Kitchener, N2G 1G3, Canada
Completed
Fredericton, E3B 5N5, Canada
Withdrawn
Chatham, N7M 4T1, Canada
Withdrawn
Lexington, 40509, United States
Withdrawn
La Jolla, 92037, United States
Terminated
Guelph, N1E 6L9, Canada
Withdrawn
Scottsdale, 85260, United States
Withdrawn
Windsor, N8W 1E6, Canada
Withdrawn
Poway, 92064, United States
Withdrawn
Saint John, E2L 4L2, Canada
Withdrawn
Toronto, M6R 1B5, Canada
Withdrawn
San Antonio, 78233, United States
Withdrawn
Toronto, M4C 3E7, Canada
Withdrawn
St. Jerome, J7Z 5T3, Canada
Withdrawn
Hamilton, L8V 1C3, Canada
Withdrawn
Waterloo, N2J 1C4, Canada
Withdrawn
St. Catharines, L2R 5K3, Canada

Primary Outcome

  • Composite endpoints of Deep vein Thrombosis (proximal and/or distal),non fatal PE and death from all causes
    date_rangeTime Frame:
    5-9 days after surgery or earlier in case of symptoms indicating deep vein Thrombosis.
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    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of DVTs (total, proximal, distal)
    date_rangeTime Frame:
    Day 6-10
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of symptomatic VTEs
    date_rangeTime Frame:
    Day 6-10
    enhanced_encryption
    Safety Issue:
    Yes
  • The composite endpoint that results from the primary endpoint by substituting VTE related death for all deaths
    date_rangeTime Frame:
    Day 6-10
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    Safety Issue:
    Yes
  • Incidence of symptomatic VTEs (total, PE, DVT)
    date_rangeTime Frame:
    Day 6-10
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6