A Phase 2 Randomized, Double Blinded (BMS-562247 and enoxaparin), Active-Controlled (enoxaparin and warfarin), Parallel-Arm, Dose Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
- Conditions
- Prevention of asymptomatic and symptomatic deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE) in subjects undergoing knee replacement surgery.
- Registration Number
- EUCTR2004-001128-19-DK
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1666
Subjects undergoing either elective unilateral total knee replacement.
Subject must be willing and able to undergo bilateral ascending contrast
venography and be able to inject (self or caregiver) enoxaparin or placebo
subcutaneously.
Men and women who are not of a childbearing potential (i.e., who are
postmenopausal or surgically sterile), of any race, and ages 18 (or legal age of
consent) to 90 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
WOCBP
Women who are pregnant or breastfeeding.
Women with a positive pregnancy test on enrollment or prior to study drug
administration.
Hereditary (first degree) or acquired bleeding or coagulation disorder.
Suspected or documented pro-thrombotic disorder, e.g., anti-thrombin or protein
S deficiency, protein C deficiency or resistance. Factor V Leiden and prothrombin
G2 mutation will be excluded only if associated with a family history of VTE in
first degree relatives.
Known or suspected history of heparin-induced thrombocytopenia.
Known intracranial or intra-ocular hemorrhage within past 5 years prior to surgery.
Gastrointestinal bleeding within 90 days of surgery; endoscopically verified ulcer
disease within 30 days before surgery; recent (within 6 months of surgery)
clinically significant hemorrhoidal bleeding.
Hematuria (gross or macroscopic) within 30 days prior to surgery.
Brain, spinal, ophthalmologic, or major surgery or trauma within 90 days prior to
surgery.
Known (VTE) disease within the past 12 months.
Uncontrolled hypertension (supine SBP > 160 mm Hg or DBP > 100 mm Hg) at the
time of screening.
Known diabetic proliferative retinopathy.
Active, severe chronic obstructive pulmonary disease (COPD), e.g., emphysema,
chronic obstructive bronchitis.
Myocardial infarction (MI), percutaneous coronary intervention (PCI; with or
without stenting), coronary artery bypass grafting (CABG), or acute coronary
syndrome (ACS) within last 6 months prior to surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method