SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00062803

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Safety/Efficacy Study
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:

MedlinePlus related topics: Blood Thinners Pulmonary Embolism

Drug Information available for: Vitamin K Warfarin SR 34006 Acenocoumarol Heparin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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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Locations

United States, California
University of California, San Diego Medical Center
San Diego, California, United States
Jerry L. Pettic VA Medical Center
Loma Linda, California, United States
United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States
Anschutz Cancer Pavilion
Aurora, Colorado, United States
United States, Florida
Brandon Regional Hospital
Brandon, Florida, United States, 33511
Bay Pines VA Medical Center
Bay Pines, Florida, United States, 33744
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
St. Joseph's Hospital
Tampa, Florida, United States, 33607
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Georgia
DeKalb Medical Center
Decatur, Georgia, United States, 30033
Medical College of Georgia
Augusta, Georgia, United States, 30912
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
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Boston Medical Center
Boston, Massachusetts, United States
United States, Michigan
William Beaumont Hospital
Troy, Michigan, United States, 48085
St. Joseph Mercy - Oakland
Pontiac, Michigan, United States, 48341
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New Mexico
Lovelace Health Systems, Clinical Thrombosis Center
Albuquerque, New Mexico, United States, 87108
United States, New York
Mount Sinai School of Medicine
New York, New York, United States
Winthrop University Hospital
Mineola, New York, United States, 11501
Winthrop Pulmonary Associates
Mineola, New York, United States, 11501
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
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Akron General Medical Center
Akron, Ohio, United States, 44307
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
Crozer-Chester Medical Center
Upland, Pennsylvania, United States, 19013
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
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
Scott & White Memorial Hospital & Clinic
Temple, Texas, United States, 76508
Northwest Texas Healthcare System
Amarillo, Texas, United States, 79106
The Methodist Hospital
Houston, Texas, United States, 77030
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
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Inova Alexandria Hospital
Alexandria, Virginia, United States, 22304
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
Portsmouth Pulmonary Associates
Chesapeake, Virginia, United States
Maryview Medical Center
Portsmouth, Virginia, United States
MedSource, Inc.
Chesapeake, Virginia, United States
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
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada
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-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC3484
Study First Received:	June 16, 2003
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00062803 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pulmonary Embolism
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Acenocoumarol
Therapeutic Uses
Cardiovascular Diseases
Heparin

ClinicalTrials.gov processed this record on November 27, 2009