Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
- Conditions
- Deep Vein Thrombosis
- Registration Number
- NCT00067093
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1452
- Confirmed acute symptomatic DVT
- Written informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
- Secondary Outcome Measures
Name Time Method symptomatic recurrent PE/DVT within 6 months.
Trial Locations
- Locations (24)
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
MIMA Century Research Associates
🇺🇸Melbourne, Florida, United States
Jackson Cardio-Vascular Clinic
🇺🇸Jacksonville, Florida, United States
St. Joseph Mercy - Oakland Research Center
🇺🇸Pontiac, Michigan, United States
DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Inova Alexandria Hospital
🇺🇸Alexandria, Virginia, United States
James Muntz
🇺🇸Houston, Texas, United States
Health System Research Center
🇺🇸Grand Forks, North Dakota, United States
Consultants in Pulmonary Medicine
🇺🇸Olathe, Kansas, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
University of Oklahoma HSC
🇺🇸Oklahoma City, Oklahoma, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Scott and White Memorial Hospital & Clinic
🇺🇸Temple, Texas, United States
William Dittman
🇺🇸Spokane, Washington, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Lovelace Health Systems
🇺🇸Albuquerque, New Mexico, United States
Loyola University of Chicago
🇺🇸Maywood, Illinois, United States
Pulmonary Associates
🇺🇸Fredericksburg, Virginia, United States
McGuire VAMC
🇺🇸Richmond, Virginia, United States