SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
- Conditions
- Pulmonary EmbolismDeep Vein Thrombosis
- Registration Number
- NCT00071279
- Lead Sponsor
- Sanofi
- Brief Summary
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.
In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.
Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1215
- Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
- Written informed consent
- Legal age limitations (country specific)
- Indication for anticoagulation other than PE or DVT
- Creatinine clearance (CLcr) <10 mL/min, severe hepatic disease, or bacterial endocarditis
- Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
- Life expectancy <3 months
- Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 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, women who are breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptomatic recurrent PE/DVT during the 6-month study treatment period.
- Secondary Outcome Measures
Name Time Method Major bleeding during the 6-month study treatment period.
Trial Locations
- Locations (39)
Cardinal Bernardin Cancer Center
🇺🇸Maywood, Illinois, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Spartanburg Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Jacksonville Cardiovascular Clinic
🇺🇸Jacksonville, Florida, United States
Pulmonary Associates of Brandon
🇺🇸Brandon, Florida, United States
St. Joseph Mercy - Oakland Clinical Research Office
🇺🇸Pontiac, Michigan, United States
Melbourne Internal Medical Associates (MIMA)
🇺🇸Palm Bay, Florida, United States
William Beaumont Hospital / Clinical Research Center
🇺🇸Royal Oak, Michigan, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Bay Pines VA Medical Center
🇺🇸Bay Pines, Florida, United States
Melbourne Internal Medicine Associates (MIMA)
🇺🇸Melbourne, Florida, United States
Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office
🇺🇸Bloomfield Hills, Michigan, United States
Scott and White Memorial Hospital and Clinic
🇺🇸Temple, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
St. Joseph Mercy - Oakland
🇺🇸Pontiac, Michigan, United States
William Beaumont Hospital Troy
🇺🇸Troy, Michigan, United States
Lovelace Sandia Health Systems, Clinical Thrombosis Center
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Hospital
🇺🇸Albuquerque, New Mexico, United States
Crozer-Chester Medical Center
🇺🇸Upland, Pennsylvania, United States
Pulmonary Specialists/Spokane Respiratory Consultants
🇺🇸Spokane, Washington, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Pulmonary Associates of Fredericksburg, Inc.
🇺🇸Fredericksburg, Virginia, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Clinical Pharmacology Services
🇺🇸Tampa, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Lung & Chest Medical Associates
🇺🇸Spartanburg, South Carolina, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Inova Alexandria Hospital
🇺🇸Alexandria, Virginia, United States
The University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec
🇨🇦Sainte-Foy, Quebec, Canada
The Ottawa Hospital, Civic Campus
🇨🇦Ottawa, Ontario, Canada
Kelowna General Hospital
🇨🇦Kelowna, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada