Pulmonary Embolism Clinical Trial
Official title:
The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism
Verified date | April 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | October 2005 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT) - Written informed consent Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | QEII Health Sciences Center | Halifax | Nova Scotia |
Canada | Hamilton Health Sciences - General Hospital | Hamilton | Ontario |
Canada | Kelowna General Hospital | Kelowna | British Columbia |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Ottawa Hospital - Civic Campus | Ottawa | Ontario |
Canada | Hotel-Dieu de St-Jerome | St-Jerome | Quebec |
Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | Humber River Regional Hospital | Weston | Ontario |
Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
United States | Akron General Medical Center | Akron | Ohio |
United States | Lovelace Health Systems, Clinical Thrombosis Center | Albuquerque | New Mexico |
United States | Inova Alexandria Hospital | Alexandria | Virginia |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Northwest Texas Healthcare System | Amarillo | Texas |
United States | Medical College of Georgia | Augusta | Georgia |
United States | Anschutz Cancer Pavilion | Aurora | Colorado |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Bay Pines VA Medical Center | Bay Pines | Florida |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Brandon Regional Hospital | Brandon | Florida |
United States | University of North Carolina Hospitals | Chapel Hill | North Carolina |
United States | MedSource, Inc. | Chesapeake | Virginia |
United States | Portsmouth Pulmonary Associates | Chesapeake | Virginia |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | DeKalb Medical Center | Decatur | Georgia |
United States | University of Colorado Hospital | Denver | Colorado |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Pulmonary Associates of Fredericksburg, Inc. | Fredericksburg | Virginia |
United States | Altru Health System Hospital | Grand Forks | North Dakota |
United States | The Methodist Hospital | Houston | Texas |
United States | Christus St. Patrick Hospital | Lake Charles | Louisiana |
United States | Jerry L. Pettic VA Medical Center | Loma Linda | California |
United States | Loyola University Medical Center and Outpatient Clinic | Maywood | Illinois |
United States | Holmes Regional Medical Center | Melbourne | Florida |
United States | Baptist Memorial Hospital Memphis | Memphis | Tennessee |
United States | The West Cancer Clinic | Memphis | Tennessee |
United States | Jackson Memorial Hospital | Miami | Florida |
United States | Winthrop Pulmonary Associates | Mineola | New York |
United States | Winthrop University Hospital | Mineola | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | St. Luke's-Roosevelt Hospital Center | New York | New York |
United States | INTEGRIS Southwest Medical Center | Oklahoma City | Oklahoma |
United States | Oklahoma City VA Medical Center | Oklahoma City | Oklahoma |
United States | OU Medical Center | Oklahoma City | Oklahoma |
United States | Saint Anthony Hospital | Oklahoma City | Oklahoma |
United States | Olathe Medical Center | Olathe | Kansas |
United States | St. Joseph Mercy - Oakland | Pontiac | Michigan |
United States | Maryview Medical Center | Portsmouth | Virginia |
United States | McGuire VA Medical Center | Richmond | Virginia |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | University Hospital | Salt Lake City | Utah |
United States | University of California, San Diego Medical Center | San Diego | California |
United States | Swedish Medical Center | Seattle | Washington |
United States | Mary Black Memorial Hospital | Spartanburg | South Carolina |
United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Sacred Heart Medical Center | Spokane | Washington |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | St. Joseph's Hospital | Tampa | Florida |
United States | Scott & White Memorial Hospital & Clinic | Temple | Texas |
United States | Medical College of Ohio | Toledo | Ohio |
United States | William Beaumont Hospital | Troy | Michigan |
United States | The University of Texas Health Center at Tyler | Tyler | Texas |
United States | Crozer-Chester Medical Center | Upland | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months. | |||
Secondary | symptomatic recurrent PE/DVT within 6 months. |
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