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
๐บ๐ธMaywood, Illinois, United States
Sinai Hospital of Baltimore
๐บ๐ธBaltimore, Maryland, United States
University of Alberta
๐จ๐ฆEdmonton, Alberta, Canada
Jewish General Hospital
๐จ๐ฆMontreal, Quebec, Canada
Spartanburg Pharmaceutical Research
๐บ๐ธSpartanburg, South Carolina, United States
Swedish Medical Center
๐บ๐ธSeattle, Washington, United States
St. Boniface General Hospital
๐จ๐ฆWinnipeg, Manitoba, Canada
Jacksonville Cardiovascular Clinic
๐บ๐ธJacksonville, Florida, United States
Pulmonary Associates of Brandon
๐บ๐ธBrandon, Florida, United States
St. Joseph Mercy - Oakland Clinical Research Office
๐บ๐ธPontiac, Michigan, United States
Melbourne Internal Medical Associates (MIMA)
๐บ๐ธPalm Bay, Florida, United States
William Beaumont Hospital / Clinical Research Center
๐บ๐ธRoyal Oak, Michigan, United States
Lehigh Valley Hospital
๐บ๐ธAllentown, Pennsylvania, United States
Bay Pines VA Medical Center
๐บ๐ธBay Pines, Florida, United States
Melbourne Internal Medicine Associates (MIMA)
๐บ๐ธMelbourne, Florida, United States
Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office
๐บ๐ธBloomfield Hills, Michigan, United States
Scott and White Memorial Hospital and Clinic
๐บ๐ธTemple, Texas, United States
The Methodist Hospital
๐บ๐ธHouston, Texas, United States
St. Joseph Mercy - Oakland
๐บ๐ธPontiac, Michigan, United States
William Beaumont Hospital Troy
๐บ๐ธTroy, Michigan, United States
Lovelace Sandia Health Systems, Clinical Thrombosis Center
๐บ๐ธAlbuquerque, New Mexico, United States
University of New Mexico Hospital
๐บ๐ธAlbuquerque, New Mexico, United States
Crozer-Chester Medical Center
๐บ๐ธUpland, Pennsylvania, United States
Pulmonary Specialists/Spokane Respiratory Consultants
๐บ๐ธSpokane, Washington, United States
Sacred Heart Medical Center
๐บ๐ธSpokane, Washington, United States
Pulmonary Associates of Fredericksburg, Inc.
๐บ๐ธFredericksburg, Virginia, United States
Henry Ford Hospital
๐บ๐ธDetroit, Michigan, United States
Clinical Pharmacology Services
๐บ๐ธTampa, Florida, United States
Loyola University Medical Center
๐บ๐ธMaywood, Illinois, United States
Medical College of Georgia
๐บ๐ธAugusta, Georgia, United States
Lung & Chest Medical Associates
๐บ๐ธSpartanburg, South Carolina, United States
McGuire VA Medical Center
๐บ๐ธRichmond, Virginia, United States
Spartanburg Regional Medical Center
๐บ๐ธSpartanburg, South Carolina, United States
Inova Alexandria Hospital
๐บ๐ธAlexandria, Virginia, United States
The University of Texas Health Center at Tyler
๐บ๐ธTyler, Texas, United States
Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec
๐จ๐ฆSainte-Foy, Quebec, Canada
The Ottawa Hospital, Civic Campus
๐จ๐ฆOttawa, Ontario, Canada
Kelowna General Hospital
๐จ๐ฆKelowna, British Columbia, Canada
St. Paul's Hospital
๐จ๐ฆVancouver, British Columbia, Canada