Prevention of asymptomatic and symptomatic deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE) in subjects undergoing knee replacement surgery.
Conditions
Interventions
Product Name: BMS-562247-01
Product Code: BMS-562247-01
Pharmaceutical Form: Tablet
CAS Number: 503612-47-3
Current Sponsor code: BMS-562247-01 (laboratory code)
Concentration unit: mg milligram(s)
Co
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dose-response relationship among the three QD and three BID doses of oral BMS-562247 on the composite endpoint of adjudicated VTE events (asymptomatic and symptomatic DVT and non-fatal PE) and all cause death in subjects treated for 12+/- 2 days following elective unilateral total knee replacement surgery.;Secondary Objective: To assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30mg q 12h enoxaparin and oral warfarin on the composite endpoint of adjudicated VTE events (asymptomatic and symptomatic DVT and non-fatal PE) and all cause death in subjects treated with double-blind study medication for 12+/- 2 days following elective total unilateral knee replacement surgery. To assess the effect of each QD and BID dose of BMS- 562247 versus subcutaneous 30 mg q 12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with double-blind study medication for 12 +/- 2 days following elective total elective knee replacement surgery. To assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q 12h enoxaparin and oral warfarin on adjudicated minor bleeding events in subjects treated with double-blind study medication for 12+/- 2 days following elective total unilateral knee replacement surgery.;Primary end point(s): Composite endpoint of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death after 12±2 days of study medication in subjects undergoing elective unilateral total knee replacement surgery. | — |
Countries
Denmark
Outcome results
None listed