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.Revised Protocol 02, Incorporates Amendments 02, 04 and Administrative Letter dated 14-Apr-2006;+ Pharmacogenetics Blood Sample Amendment version 01 dated 29-June-2005. - Botticelli

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 660

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

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 < 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.
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.

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

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