A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis.Protocol version 3.0 dated 29-June-2005 - Botticelli
- Conditions
- Acute Symptomatic Deep Vein Thrombosis
- Registration Number
- EUCTR2005-001388-71-AT
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
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 who are not of childbearing potential (i.e. who are post-menopausal or surgically sterile) and men ages 18( or legal age of consent) to 90.
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
1) Legal lower age limitations (country specific)
2) Women of childbearing potential or who are pregnant or breast feeding
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) Participation in another pharmacotherapeutic study within 30 days
7) Creatinine clearance < 30 ml/min, impaired liver function (ALT > 3 x ULN), or bacterial endocarditis
8) Life expectancy <6 months
9) Active bleeding or high risk for bleeding contraindicating treatment with LMWH, fondaparinux or VKA
10) Systolic blood pressure >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br><br>To determine the optimal dose and regimen of apixaban for use in Phase III.;Secondary Objective: none.;Primary end point(s): Efficacy:<br>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<br><br>Safety:The primary safety outcome is the composite of major bleeding and clinically relevant non-major bleeding.<br>Other safety outcome measures will include (S)AEs and death from all causes.<br>
- Secondary Outcome Measures
Name Time Method