SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Embolism	Drug: SR34006; Drug: (LMW)heparin; Drug: Warfarin VKA; Drug: Acenocoumarol VKA	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Masking:	None (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
Study Start Date :	June 2003
Actual Primary Completion Date :	October 2005
Actual Study Completion Date :	October 2005

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Secondary Outcome Measures :

1. symptomatic recurrent PE/DVT within 6 months.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

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 Pulmonary Associates
Mineola, New York, United States, 11501
Winthrop University Hospital
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
Saint Anthony Hospital
Oklahoma City, Oklahoma, United States, 73101
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
INTEGRIS Southwest Medical Center
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Crozer-Chester Medical Center
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 23903
Mary Black Memorial Hospital
Spartanburg, South Carolina, United States, 29307
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.

van Gogh Investigators, Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104.

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00062803 History of Changes
Other Study ID Numbers:	EFC3484
First Posted:	June 17, 2003
Last Update Posted:	April 29, 2009
Last Verified:	April 2009

Additional relevant MeSH terms:

Embolism; Pulmonary Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Calcium heparin; SANORG 34006; Heparin; Warfarin; Acenocoumarol; Vitamin K; Anticoagulants; Fibrinolytic Agents	Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors