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

Deep-Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252005
• Other study ID #: CV185-017
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2005
• Last updated: February 27, 2010
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: August 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep-Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Czech Republic,  France,  Israel,  Italy,  Netherlands,  Poland,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	compression ultrasound and perfusion lung scan.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm