SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
- Conditions
- Pulmonary Embolism
- Registration Number
- NCT00062803
- Lead Sponsor
- Sanofi
- Brief Summary
Patients who have a pulmonary embolism (blood clot in the lung) 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, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.
Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
- Written informed consent
- Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
- Other indication for VKA than PE/DVT
- More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization
- Participation in another pharmacotherapeutic study within the prior 30 days
- Creatinine clearance <10 mL/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 or diastolic blood pressure >110 mm Hg
- Pregnancy or childbearing potential without proper contraceptive measures or women who are breastfeeding
- Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin, enoxaparin, or tinzaparin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- 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 (65)
Loyola University Medical Center and Outpatient Clinic
🇺🇸Maywood, Illinois, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Mary Black Memorial Hospital
🇺🇸Spartanburg, South Carolina, United States
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
The Methodist Hospital
🇺🇸Houston, Texas, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Scott & White Memorial Hospital & Clinic
🇺🇸Temple, Texas, United States
The University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
Crozer-Chester Medical Center
🇺🇸Upland, Pennsylvania, United States
Pulmonary Associates of Fredericksburg, Inc.
🇺🇸Fredericksburg, Virginia, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Inova Alexandria Hospital
🇺🇸Alexandria, Virginia, United States
Portsmouth Pulmonary Associates
🇺🇸Chesapeake, Virginia, United States
Olathe Medical Center
🇺🇸Olathe, Kansas, United States
Altru Health System Hospital
🇺🇸Grand Forks, North Dakota, United States
Jerry L. Pettic VA Medical Center
🇺🇸Loma Linda, California, United States
University of California, San Diego Medical Center
🇺🇸San Diego, California, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Lovelace Health Systems, Clinical Thrombosis Center
🇺🇸Albuquerque, New Mexico, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
St. Luke's-Roosevelt Hospital Center
🇺🇸New York, New York, United States
St. Joseph Mercy - Oakland
🇺🇸Pontiac, Michigan, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
INTEGRIS Southwest Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma City VA Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Medical College of Ohio
🇺🇸Toledo, Ohio, United States
Saint Anthony Hospital
🇺🇸Oklahoma City, Oklahoma, United States
The West Cancer Clinic
🇺🇸Memphis, Tennessee, United States
Kelowna General Hospital
🇨🇦Kelowna, British Columbia, Canada
Northwest Texas Healthcare System
🇺🇸Amarillo, Texas, United States
Maryview Medical Center
🇺🇸Portsmouth, Virginia, United States
MedSource, Inc.
🇺🇸Chesapeake, Virginia, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Hotel-Dieu de St-Jerome
🇨🇦St-Jerome, Quebec, Canada
Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Winthrop Pulmonary Associates
🇺🇸Mineola, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Bay Pines VA Medical Center
🇺🇸Bay Pines, Florida, United States
Brandon Regional Hospital
🇺🇸Brandon, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Baptist Memorial Hospital Memphis
🇺🇸Memphis, Tennessee, United States
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Christus St. Patrick Hospital
🇺🇸Lake Charles, Louisiana, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
William Beaumont Hospital
🇺🇸Troy, Michigan, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
University Health Network, Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University of North Carolina Hospitals
🇺🇸Chapel Hill, North Carolina, United States
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University Hospital
🇺🇸Salt Lake City, Utah, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Hamilton Health Sciences - General Hospital
🇨🇦Hamilton, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States