Clinical trial NCT00252005: Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study
Official title: Protocol CV185017: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Deep-Vein Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.


Eligibility criteria: Inclusion Criteria:

1. Subjects must be willing and able to give written informed consent.
2. Confirmed acute symptomatic DVT, i.e., proximal vein or extensive calf-vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation area) without concomitant symptomatic PE.
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.

WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea for 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \> 35mIU/mL\]. Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Women with a positive pregnancy test on enrollment or prior to study drug administration.
3. More than 24 hours pre-randomization treatment with therapeutic dosages of unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or more than a single starting dose of vitamin K antagonist (VKA) prior to randomization.
4. Uncontrolled hypertension: systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 110 mm Hg.
5. Creatinine clearance \< 30 mL/min
6. Impaired liver function (ALT \> 3 x ULN)
7. Use of ASA \> 165 mg/day
8. 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.
9. Azole antifungals (e.g., ketoconazole), HIV protease inhibitors (e.g., ritonavir) and macrolide antibiotics (e.g., erythromycin).

NOTE: topical azole antifungal agents are permitted.

Primary outcomes:
measure: The composite of symptomatic recurrent venous thromboembolism (i.e., recurrent deep-vein thrombosis or fatal or non-fatal pulmonary embolism and deterioration of the thrombotic burden as assessed by repeat bilateral
measure: compression ultrasound and perfusion lung scan.
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: Chapel Hill
country: United States
facility: Local Institution
state: North Carolina
city: San Antonio
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facility: Local Institution
state: Texas
city: Fredericksburg
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facility: Local Institution
state: Virginia
city: Seattle
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facility: Local Institution
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facility: Local Institution
state: Australian Capital Territory
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facility: Local Institution
state: New South Wales
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facility: Local Institution
state: New South Wales
city: Randwick
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facility: Local Institution
state: New South Wales
city: Bedford Park
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facility: Local Institution
state: South Australia
city: Box Hill
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facility: Local Institution
state: Victoria
city: Clayton
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facility: Local Institution
state: Victoria
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facility: Local Institution
state: Victoria
city: Perth
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facility: Local Institution
state: Western Australia
city: Graz
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facility: Local Institution
city: Wien
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facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Karlovy Vary
country: Czech Republic
facility: Local Institution
city: Ostrava 1
country: Czech Republic
facility: Local Institution
city: Ostrava Poruba
country: Czech Republic
facility: Local Institution
city: Plzen
country: Czech Republic
facility: Local Institution
city: Praha 1
country: Czech Republic
facility: Local Institution
city: Praha 2
country: Czech Republic
facility: Local Institution
city: Usti Nad Labem
country: Czech Republic
facility: Local Institution
city: Angers
country: France
facility: Local Institution
city: Brest Cedex
country: France
facility: Local Institution
city: Clermont-Ferrand Cedex 01
country: France
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: Limoges
country: France
facility: Local Institution
city: Montpellier
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Saint Etienne
country: France
facility: Local Institution
city: Afula
country: Israel
facility: Local Institution
city: Ashkelon
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Holon
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Kfar-Saba
country: Israel
facility: Local Institution
city: Petach Tikva
country: Israel
facility: Local Institution
city: Safed
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Chieti
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Piacenza
country: Italy
facility: Local Institution
city: Reggio Emilia
country: Italy
facility: Local Institution
city: Treviso
country: Italy
facility: Local Institution
city: Venezia
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Arnhem
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Hoofddorp
country: Netherlands
facility: Local Institution
city: Maastricht
country: Netherlands
facility: Local Institution
city: Zwolle
country: Netherlands
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Bloemfontein
country: South Africa
facility: Local Institution
state: Free State
city: Centurion
country: South Africa
facility: Local Institution
state: Gauteng
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Sunninghill
country: South Africa
facility: Local Institution
state: Gauteng
city: Somerset West
country: South Africa
facility: Local Institution
state: Western Cape
city: Boras
country: Sweden
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Halmstad
country: Sweden
facility: Local Institution
city: Jonkoping
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Vastervik
country: Sweden
facility: Local Institution
Study officials:
References: