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

• ClinicalTrials.gov Identifier: NCT00252005
• Recruitment Status: Completed
• First Posted: November 11, 2005
• Last Update Posted: March 2, 2010
• Sponsor: Bristol-Myers Squibb
• Information provided by: Bristol-Myers Squibb

Tracking Information

• First Submitted Date: November 9, 2005
• First Posted Date: November 11, 2005
• Last Update Posted Date: March 2, 2010
• Study Start Date: November 2005
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2006)

• 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.

• Original Primary Outcome Measures (submitted: November 9, 2005): 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 confir
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Deep-Vein Thrombosis
• Intervention: Drug: Apixaban
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: November 9, 2005): 520
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2007
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Czech Republic, France, Israel, Italy, Netherlands, Poland, South Africa, Sweden, United States

Administrative Information

• NCT Number: NCT00252005
• Other Study ID Numbers: CV185-017
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bristol-Myers Squibb
• Verification Date: August 2008