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

NCT00252005 | Completed Phase 2

• 1 other identifier: CV185-017
• Study Type: interventional
• Target: 520
• Locations: 10 countries
• Sites: 63

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.

Conditions

Deep-Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

Apixaban DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be willing and able to give written informed consent.
• 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.
• 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.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• 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.
• Uncontrolled hypertension: systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 110 mm Hg.
• Creatinine clearance \< 30 mL/min
• Impaired liver function (ALT \> 3 x ULN)
• Use of ASA \> 165 mg/day
• 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.
• Azole antifungals (e.g., ketoconazole), HIV protease inhibitors (e.g., ritonavir) and macrolide antibiotics (e.g., erythromycin).
• NOTE: topical azole antifungal agents are permitted.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (72)

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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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Vienna, Austria

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Hradec Králové, Czechia

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Karlovy Vary, Czechia

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Ostrava, Czechia

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Ostrava Poruba, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Ústí nad Labem, Czechia

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Angers, France

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Brest, France

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Clermont-Ferrand, France

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Créteil, 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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Petah 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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Milan, Italy

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Padua, 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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Warsaw, 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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Borås, Sweden

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Gothenburg, Sweden

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Halmstad, Sweden

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Jönköping, Sweden

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Stockholm, Sweden

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Västervik, Sweden

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MeSH Terms

Conditions

Venous Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: November 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: March 2, 2010

Record last verified: 2008-08

Locations

US (5); AU (2); IT (8); FR (8); NL (6); SE (6); IL (9); PL (7); ZA (5); CZ (7)