Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study

Overview[ - collapse ][ - ]

Purpose 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.
ConditionDeep-Vein Thrombosis
InterventionDrug: Apixaban
PhasePhase 2
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT00252005
First ReceivedNovember 9, 2005
Last UpdatedFebruary 27, 2010
Last verifiedAugust 2008

Tracking Information[ + expand ][ + ]

First Received DateNovember 9, 2005
Last Updated DateFebruary 27, 2010
Start DateNovember 2005
Estimated Primary Completion DateFebruary 2007
Current Primary Outcome Measures
  • 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
  • compression ultrasound and perfusion lung scan.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleOral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study
Official TitleProtocol 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionDeep-Vein Thrombosis
InterventionDrug: Apixaban
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment520
Estimated Completion DateFebruary 2007
Estimated Primary Completion DateFebruary 2007
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Australia, Austria, Czech Republic, France, Israel, Italy, Netherlands, Poland, South Africa, Sweden

Administrative Information[ + expand ][ + ]

NCT Number NCT00252005
Other Study ID NumbersCV185-017
Has Data Monitoring CommitteeNot Provided
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Not Provided
Verification DateAugust 2008

Locations[ + expand ][ + ]

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Albuquerque, New Mexico, United States
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Chapel Hill, North Carolina, United States
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San Antonio, Texas, United States
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Fredericksburg, Virginia, United States
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Seattle, Washington, United States
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Garran, Australian Capital Territory, Australia
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Caringbah, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Randwick, New South Wales, Australia
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Bedford Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Clayton, Victoria, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
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Graz, Austria
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Wien, Austria
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Hradec Kralove, Czech Republic
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Karlovy Vary, Czech Republic
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Ostrava 1, Czech Republic
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Ostrava Poruba, Czech Republic
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Plzen, Czech Republic
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Praha 1, Czech Republic
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Praha 2, Czech Republic
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Usti Nad Labem, Czech Republic
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Angers, France
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Brest Cedex, France
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Clermont-Ferrand Cedex 01, France
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Creteil, France
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Limoges, France
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Montpellier, France
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Paris, France
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Saint Etienne, France
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Afula, Israel
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Ashkelon, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar-Saba, Israel
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Petach Tikva, Israel
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Safed, Israel
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Tel Aviv, Israel
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Chieti, Italy
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Milano, Italy
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Padova, Italy
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Pavia, Italy
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Piacenza, Italy
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Reggio Emilia, Italy
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Treviso, Italy
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Venezia, Italy
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Groningen, Netherlands
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Hoofddorp, Netherlands
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Maastricht, Netherlands
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Zwolle, Netherlands
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Bydgoszcz, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Poznan, Poland
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Warszawa, Poland
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Wroclaw, Poland
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Bloemfontein, Free State, South Africa
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Centurion, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Sunninghill, Gauteng, South Africa
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Somerset West, Western Cape, South Africa
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Boras, Sweden
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Goteborg, Sweden
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Halmstad, Sweden
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Jonkoping, Sweden
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Stockholm, Sweden
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Vastervik, Sweden