Total Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT. MedDRA version: 9.1 Level: LLT Classification code 10051055 Term: Deep vein thrombosis MedDRA version: 9.1 Level: LLT Classification code 10037377 Term: Pulmonary embolism MedDRA version: 9.1 Level: LLT Classification code 10049918 Term: Deep venous thrombosis proximal
Conditions
Sponsors
Bristol Myers Squibb
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be willing and able to give written informed consent. Consent to participate in the study must be obtained prior to screening. 2) Subjects hospitalized due to congestive heart failure, acute respiratory failure or with infection (without septic shock), acute rheumatic disorder, or inflammatory bowel disease. 3) Except for subjects with congestive heart failure or respiratory failure, subjects must have one additional factor including: a) age = 75 b) previous documented VTE or history of VTE for which they received anticoagulation for at least 6 weeks c) cancer d) BMI = 30 (See Appendix 4 for BMI chart) e) estrogenic hormone therapy f) chronic heart or respiratory failure 4) Expected hospitalization of = 3 days after randomization 5) Severely or moderately restricted mobility (i.e. bedridden or limited to chair, walking to bathroom or within room; see section 6.9.1) 6) Men and women, of any race, at least 40 years of age Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product. 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: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period 2) WOCBP using a prohibited contraceptive method 3) Women who are pregnant or breastfeeding 4) Women with a positive pregnancy test on enrollment or prior to investigational product administration 5) Subjects with a confirmed VTE 6) Subjects with diseases requiring ongoing treatment with a parenteral or oral anticoagulant, e.g. subjects with mechanical valves, warfarin eligible atrial fibrillation 7) Subjects with conditions requiring ongoing treatment with parenteral or two or more oral antiplatelet agents 8) Active liver disease as evidenced by abnormal laboratory test findings (see physical and laboratory findings below) 9) Anemia or thrombocytopenia as evidenced by abnormal laboratory test findings (see physical and laboratory findings below) 10) Severe renal disease as evidenced by creatinine clearance 3 X ULN or • ALT or AST > 2 X ULN without identification of an alternative causative factor or • bilirubin (direct or total) > 1.5 X ULN (unless in an alternative causative factor [e.g., Gilbert’s syndrome] is identified) 22) Known or suspected allergies to enoxaparin or prior heparin-induced thrombocytopenia 23) Use of bevacizumab (Avastin®) therapy within the previous 6 months or planned use during the study period 24) Presently receiving oral anticoagulant therapy 25) Presently receiving dual oral antiplatelet therapy or aspirin at a dose > 165 mg. 26) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study 27) Administration of any investigational drug currently or within 30 days prior to planned enrollment into this study 28) Subjects unwilling or unable to comply with study medication instructions including the use of enoxaparin or matching placebo for the minimum treatment duration of 6 days 29) Subjects unwilling or unable to comply with study procedures (e.g., bilateral compression ultrasound) specified in the protocol 30) Subjects who have previously been randomized in an experimental study of apixaban
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a minimum period of 6 days, in subjects with acute medical illness. Total VTE is defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT detected by bilateral compression ultrasound.;Secondary Objective: Efficacy: • To demonstrate that oral administration of apixaban 2.5 mg BID is not inferior to subcutaneous administration of enoxaparin 40 mg QD for the prevention of total VTE and VTE-related death occurring up to the time of discontinuation of parenteral therapy. • To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total VTE and all cause death compared to subcutaneous administration of enoxaparin 40 mg QD. • To assess the effect of orally-administered apixaban 2.5 mg BID on the incidence and time to occurrence of symptomatic PE and symptomatic DVT. • To assess the effect of orally-administered apixaban 2.5 mg BID on the rate of all-cause mortality at 30 and 90 days after randomization. Safety • To demonstrate that orally administered apixaban 2.5 mg BID for 30 days is generally safe and well tolerated in this patient population.;Primary end point(s): The primary efficacy outcome measure is a composite endpoint of adjudicated total VTE and VTE-related death during 30 days of double-blind treatment, in acutely ill medical subjects during and following hospitalization. | — |
Countries
Austria, Belgium, Denmark, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed