Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
2 other identifiers
interventional
1,452
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 11, 2003
CompletedFirst Posted
Study publicly available on registry
August 13, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedApril 6, 2011
April 1, 2011
2.3 years
August 11, 2003
April 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
Secondary Outcomes (1)
symptomatic recurrent PE/DVT within 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed acute symptomatic DVT
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (24)
University of Colorado Health Sciences Center
Denver, Colorado, 80129, United States
Jackson Cardio-Vascular Clinic
Jacksonville, Florida, 32216, United States
MIMA Century Research Associates
Melbourne, Florida, 32901, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
DeKalb Medical Center
Decatur, Georgia, 30033-6136, United States
Northwestern University
Chicago, Illinois, 60611, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Loyola University of Chicago
Maywood, Illinois, 60513, United States
Consultants in Pulmonary Medicine
Olathe, Kansas, 66061, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
St. Joseph Mercy - Oakland Research Center
Pontiac, Michigan, 48341, United States
Lovelace Health Systems
Albuquerque, New Mexico, 87108, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Health System Research Center
Grand Forks, North Dakota, 58201, United States
University of Oklahoma HSC
Oklahoma City, Oklahoma, 73104, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
James Muntz
Houston, Texas, 77030, United States
Scott and White Memorial Hospital & Clinic
Temple, Texas, 76508, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Pulmonary Associates
Fredericksburg, Virginia, 22401, United States
McGuire VAMC
Richmond, Virginia, 23249, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
William Dittman
Spokane, Washington, 99203, United States
Related Publications (2)
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.
PMID: 19348685DERIVEDvan 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.
PMID: 17855670DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 11, 2003
First Posted
August 13, 2003
Study Start
May 1, 2003
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
April 6, 2011
Record last verified: 2011-04