Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)

Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Drug: Unfractionated heparin; Drug: SanOrg34006; Drug: LMW heparin; Drug: Vitamin K antagonist (VKA)

• Study Type: Interventional
• Enrollment (Actual): 1452
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80129
      • University of Colorado Health Sciences Center
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jackson Cardio-Vascular Clinic
    • Melbourne, Florida, United States, 32901
      • MIMA Century Research Associates
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
    • Decatur, Georgia, United States, 30033-6136
      • Dekalb Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Evanston, Illinois, United States, 60201
      • Evanston Northwestern Healthcare
    • Maywood, Illinois, United States, 60513
      • Loyola University of Chicago
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Consultants in Pulmonary Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Pontiac, Michigan, United States, 48341
      • St. Joseph Mercy - Oakland Research Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Health Systems
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Health System Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma HSC
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • LeHigh Valley Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • James Muntz
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital & Clinic
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Inova Alexandria Hospital
    • Fredericksburg, Virginia, United States, 22401
      • Pulmonary Associates
    • Richmond, Virginia, United States, 23249
      • McGuire VAMC
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Spokane, Washington, United States, 99203
      • William Dittman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed acute symptomatic DVT
• Written informed consent

Exclusion Criteria:

• Legal lower age limitations
• Patients with symptomatic pulmonary embolism
• Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
• Other indication for VKA than DVT
• More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
• Participation in another pharmacotherapeutic study within the prior 30 days
• Creatinine clearance <10mL/min, severe hepatic disease or bacterial endocarditis
• Life expectancy <3 Months
• Active bleeding or high risk for bleeding
• Uncontrolled hypertension: systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.
• Pregnancy or childbearing potential without proper contraceptive measures
• Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months

Secondary Outcome Measures

Outcome Measure
symptomatic recurrent PE/DVT within 6 months.

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.
• van Gogh Investigators, Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104. doi: 10.1056/NEJMoa064247.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: August 11, 2003
• First Submitted That Met QC Criteria: August 12, 2003
• First Posted (Estimate): August 13, 2003

Study Record Updates

• Last Update Posted (Estimate): April 6, 2011
• Last Update Submitted That Met QC Criteria: April 5, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Micronutrients; Vitamins; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Heparin; Calcium heparin; Idraparinux
• Other Study ID Numbers: EFC3491; SR34006