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

February 27, 2010 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

520

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
        • Local Institution
    • New South Wales
      • Caringbah, New South Wales, Australia
        • Local Institution
      • Kogarah, New South Wales, Australia
        • Local Institution
      • Randwick, New South Wales, Australia
        • Local Institution
    • South Australia
      • Bedford Park, South Australia, Australia
        • Local Institution
    • Victoria
      • Box Hill, Victoria, Australia
        • Local Institution
      • Clayton, Victoria, Australia
        • Local Institution
      • Melbourne, Victoria, Australia
        • Local Institution
    • Western Australia
      • Perth, Western Australia, Australia
        • Local Institution
  • Austria
      • Graz, Austria
        • Local Institution
      • Wien, Austria
        • Local Institution
  • Czech Republic
      • 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, Czech Republic
        • Local Institution
  • France
      • 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, France
        • Local Institution
  • Israel
      • 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, Israel
        • Local Institution
  • Italy
      • 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, Italy
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands
        • Local Institution
      • Arnhem, Netherlands
        • Local Institution
      • Groningen, Netherlands
        • Local Institution
      • Hoofddorp, Netherlands
        • Local Institution
      • Maastricht, Netherlands
        • Local Institution
      • Zwolle, Netherlands
        • Local Institution
  • Poland
      • 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, Poland
        • Local Institution
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa
        • Local Institution
    • Gauteng
      • Centurion, Gauteng, South Africa
        • Local Institution
      • Johannesburg, Gauteng, South Africa
        • Local Institution
      • Sunninghill, Gauteng, South Africa
        • Local Institution
    • Western Cape
      • Somerset West, Western Cape, South Africa
        • Local Institution
  • Sweden
      • Boras, Sweden
        • Local Institution
      • Goteborg, Sweden
        • Local Institution
      • Halmstad, Sweden
        • Local Institution
      • Jonkoping, Sweden
        • Local Institution
      • Stockholm, Sweden
        • Local Institution
      • Vastervik, Sweden
        • Local Institution
  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Local Institution
    • Texas
      • San Antonio, Texas, United States
        • Local Institution
    • Virginia
      • Fredericksburg, Virginia, United States
        • Local Institution
    • Washington
      • Seattle, Washington, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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
compression ultrasound and perfusion lung scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (Estimate)

November 11, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep-Vein Thrombosis

Clinical Trials on Apixaban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe