Acute Symptomatic Deep Vein Thrombosis
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Confirmed acute symptomatic DVT, i.e., proximal or extensive calf-vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation area) without concomitant symptomatic PE 2) Written informed consent. 3) Women and men, ages 18 (or legal age of consent) to 90. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 1 week after the study in such a manner that the risk of pregnancy is minimized. 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) Legal lower age limitations (country specific) 2) Women who are pregnant or breastfeeding. 3) Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT 4) Indications for VKA other than DVT 5) More than 24 hours pre-randomization treatment with therapeutic dosages of UFH, LMWH or fondaparinux or more than a single starting dose of VKA prior to randomization 6) Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of apixaban (with the exception of approved medications being used for an approved indication, e.g., investigating a new dosing regimen for an approved indication). 7) Creatinine clearance 3 x ULN), or bacterial endocarditis 8) Life expectancy 200 mmHg or diastolic blood pressure >110 mmHg 11) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness 12) Any other contraindication listed in the local labeling of warfarin, acenocoumarol, phenprocoumon, fondaparinux, enoxaparin, or tinzaparin 13) Use of acetylsalicylic acid (ASA) > 165 mg/day. 14) WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 1 week after the study. 15) Women with a positive pregnancy test on enrollment or prior to study drug administration. 16) Concomitant administration of: Azole antifungals (e.g., ketoconazole), HIV protease inhibitors (e.g., ritonavir) and macrolide antibiotics (e.g., erythromycin). Note: topical azole antifungal agents are permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: none.;Main Objective: To assess efficacy and safety of 3 doses of apixaban 5 mg BID, 10 mg BID and 20 mg QD versus conventional treatment with low molecular weight heparin (LMWH) or fondaparinux and vitamin K antagonist (VKA) in the treatment of subjects with acute symptomatic deep-vein thrombosis (DVT). To determine the optimal dose and regimen of apixaban for use in Phase III.;Primary end point(s): Efficacy: The primary efficacy outcome is the composite of symptomatic recurrent venous thromboembolism (VTE) (i.e., recurrent deep-vein thrombosis [DVT] or fatal or non-fatal pulmonary embolism [PE]) and deterioriation of the thrombotic burden as assessed by repeat bilateral CUS and PLS Safety:The primary safety outcome is the composite of major bleeding and clinically relevant non-major bleeding. Other safety outcome measures will include (S)AEs and death from all causes. | — |
Countries
Czech Republic, Italy, Sweden
Outcome results
None listed