SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00062803
First received: June 16, 2003
Last updated: April 28, 2009
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Embolism |
Drug: SR34006 Drug: (LMW)heparin Drug: Warfarin VKA Drug: Acenocoumarol VKA |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Secondary Outcome Measures:
- symptomatic recurrent PE/DVT within 6 months.
| Study Start Date: | June 2003 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062803
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Hide Study LocationsLocations
| United States, California | |
| Jerry L. Pettic VA Medical Center | |
| Loma Linda, California, United States | |
| University of California, San Diego Medical Center | |
| San Diego, California, United States | |
| United States, Colorado | |
| Anschutz Cancer Pavilion | |
| Aurora, Colorado, United States | |
| University of Colorado Hospital | |
| Denver, Colorado, United States | |
| United States, Florida | |
| Bay Pines VA Medical Center | |
| Bay Pines, Florida, United States, 33744 | |
| Brandon Regional Hospital | |
| Brandon, Florida, United States, 33511 | |
| Holmes Regional Medical Center | |
| Melbourne, Florida, United States, 32901 | |
| Jackson Memorial Hospital | |
| Miami, Florida, United States, 33136 | |
| St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| DeKalb Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Loyola University Medical Center and Outpatient Clinic | |
| Maywood, Illinois, United States, 60153 | |
| United States, Kansas | |
| Olathe Medical Center | |
| Olathe, Kansas, United States | |
| United States, Louisiana | |
| Christus St. Patrick Hospital | |
| Lake Charles, Louisiana, United States, 70601 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| St. Joseph Mercy - Oakland | |
| Pontiac, Michigan, United States, 48341 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| William Beaumont Hospital | |
| Troy, Michigan, United States, 48085 | |
| United States, New Mexico | |
| Lovelace Health Systems, Clinical Thrombosis Center | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Winthrop Pulmonary Associates | |
| Mineola, New York, United States, 11501 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States | |
| St. Luke's-Roosevelt Hospital Center | |
| New York, New York, United States | |
| United States, North Carolina | |
| University of North Carolina Hospitals | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, North Dakota | |
| Altru Health System Hospital | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| Medical College of Ohio | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oklahoma | |
| INTEGRIS Southwest Medical Center | |
| Oklahoma City, Oklahoma, United States, 73109 | |
| Saint Anthony Hospital | |
| Oklahoma City, Oklahoma, United States, 73101 | |
| OU Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Oklahoma City VA Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18105 | |
| Crozer-Chester Medical Center | |
| Upland, Pennsylvania, United States, 19013 | |
| United States, South Carolina | |
| Mary Black Memorial Hospital | |
| Spartanburg, South Carolina, United States, 29307 | |
| Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 23903 | |
| United States, Tennessee | |
| Baptist Memorial Hospital Memphis | |
| Memphis, Tennessee, United States | |
| The West Cancer Clinic | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Northwest Texas Healthcare System | |
| Amarillo, Texas, United States, 79106 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Scott & White Memorial Hospital & Clinic | |
| Temple, Texas, United States, 76508 | |
| The University of Texas Health Center at Tyler | |
| Tyler, Texas, United States, 75708 | |
| United States, Utah | |
| University Hospital | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Inova Alexandria Hospital | |
| Alexandria, Virginia, United States, 22304 | |
| MedSource, Inc. | |
| Chesapeake, Virginia, United States | |
| Portsmouth Pulmonary Associates | |
| Chesapeake, Virginia, United States | |
| Pulmonary Associates of Fredericksburg, Inc. | |
| Fredericksburg, Virginia, United States | |
| Maryview Medical Center | |
| Portsmouth, Virginia, United States | |
| McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122 | |
| Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99220 | |
| Argentina | |
| Buenos Aires, Argentina | |
| Australia | |
| Box Hill, Clayton, Garran, Kogarah, Ringwood East, Australia | |
| St. Leonards, South Australia, Australia | |
| Austria | |
| Graz, Austria | |
| Belgium | |
| Bruxelles, Charleroi, Leuven, Liege, Yvoir, Belgium | |
| Brazil | |
| Goiania, Porto Alegre, Sao Paulo, Salvador, Brazil | |
| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Kelowna General Hospital | |
| Kelowna, British Columbia, Canada, V1Y 1T2 | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada | |
| Canada, Manitoba | |
| St. Boniface General Hospital | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| Hamilton Health Sciences - General Hospital | |
| Hamilton, Ontario, Canada | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4G5 | |
| Ottawa Hospital - Civic Campus | |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| University Health Network, Toronto General Hospital | |
| Toronto, Ontario, Canada | |
| Humber River Regional Hospital | |
| Weston, Ontario, Canada | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada | |
| Hotel-Dieu de St-Jerome | |
| St-Jerome, Quebec, Canada | |
| Czech Republic | |
| Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague, Czech Republic | |
| Plzen, Czech Republic | |
| Denmark | |
| Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense, Denmark | |
| Roskilde, Denmark | |
| Finland | |
| Hus, Jyvaskyla, Seinajoki, Turku, Finland | |
| France | |
| Armentieres, Besancon, Bethune, Brest, Chambray Les Tours, France | |
| Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix, France | |
| Saint Malo, Valenciennes, France | |
| Tourcoing, France | |
| Germany | |
| Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen, Germany | |
| Heidelberg, Ibbenburen, Mannheim, Munchen, Germany | |
| Italy | |
| Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia, Italy | |
| Piacenza, Pisa, Reggio Emilia, Treviso, Venezia, Italy | |
| Netherlands | |
| Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen, Netherlands | |
| Haarlem, Maastricht, Nieuwegein, Netherlands | |
| Norway | |
| Oslo, Rud, Norway | |
| Poland | |
| Lublin, Warszawa, Wroclaw, Poland | |
| Spain | |
| Badalona, Madrid, Sevilla, Spain | |
| Sweden | |
| Goteborg, Jonkoping, Stockholm, Varnamo, Sweden | |
| Switzerland | |
| Basel, Bern, Lugano, Switzerland | |
| United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Additional Information:
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00062803 History of Changes |
| Other Study ID Numbers: | EFC3484 |
| Study First Received: | June 16, 2003 |
| Last Updated: | April 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Acenocoumarol Heparin Warfarin Vitamin K Vitamins Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Micronutrients Growth Substances Physiological Effects of Drugs Antifibrinolytic Agents Hemostatics Coagulants |
ClinicalTrials.gov processed this record on May 16, 2013