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

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

Sponsoren

Hauptsponsor: Sanofi

Quelle Sanofi
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum June 2003
Fertigstellungstermin October 2005
Primäres Abschlussdatum October 2005
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Sekundäres Ergebnis
Messen Zeitfenster
symptomatic recurrent PE/DVT within 6 months.
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: SR34006

Interventionsart: Drug

Interventionsname: (LMW)heparin

Interventionsart: Drug

Interventionsname: Warfarin VKA

Interventionsart: Drug

Interventionsname: Acenocoumarol VKA

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
ICD CSD Study Director Sanofi
Ort
Einrichtung:
Jerry L. Pettic VA Medical Center | Loma Linda, California, United States
University of California, San Diego Medical Center | San Diego, California, United States
Anschutz Cancer Pavilion | Aurora, Colorado, United States
University of Colorado Hospital | Denver, Colorado, United States
Bay Pines VA Medical Center | Bay Pines, Florida, 33744, United States
Brandon Regional Hospital | Brandon, Florida, 33511, United States
Holmes Regional Medical Center | Melbourne, Florida, 32901, United States
Jackson Memorial Hospital | Miami, Florida, 33136, United States
St. Joseph's Hospital | Tampa, Florida, 33607, United States
Medical College of Georgia | Augusta, Georgia, 30912, United States
DeKalb Medical Center | Decatur, Georgia, 30033, United States
Loyola University Medical Center and Outpatient Clinic | Maywood, Illinois, 60153, United States
Olathe Medical Center | Olathe, Kansas, United States
Christus St. Patrick Hospital | Lake Charles, Louisiana, 70601, United States
Sinai Hospital of Baltimore | Baltimore, Maryland, United States
Boston Medical Center | Boston, Massachusetts, United States
Baystate Medical Center | Springfield, Massachusetts, 01199, United States
Henry Ford Hospital | Detroit, Michigan, 48202, United States
St. Joseph Mercy - Oakland | Pontiac, Michigan, 48341, United States
William Beaumont Hospital | Royal Oak, Michigan, 48073, United States
William Beaumont Hospital | Troy, Michigan, 48085, United States
Lovelace Health Systems, Clinical Thrombosis Center | Albuquerque, New Mexico, 87108, United States
Winthrop Pulmonary Associates | Mineola, New York, 11501, United States
Winthrop University Hospital | Mineola, New York, 11501, 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
University of North Carolina Hospitals | Chapel Hill, North Carolina, 27599, United States
Altru Health System Hospital | Grand Forks, North Dakota, 58201, United States
Akron General Medical Center | Akron, Ohio, 44307, United States
Riverside Methodist Hospital | Columbus, Ohio, 43214, United States
Medical College of Ohio | Toledo, Ohio, 43614, United States
Saint Anthony Hospital | Oklahoma City, Oklahoma, 73101, United States
Oklahoma City VA Medical Center | Oklahoma City, Oklahoma, 73104, United States
OU Medical Center | Oklahoma City, Oklahoma, 73104, United States
INTEGRIS Southwest Medical Center | Oklahoma City, Oklahoma, 73109, United States
Lehigh Valley Hospital | Allentown, Pennsylvania, 18105, United States
Crozer-Chester Medical Center | Upland, Pennsylvania, 19013, United States
Spartanburg Regional Medical Center | Spartanburg, South Carolina, 23903, United States
Mary Black Memorial Hospital | Spartanburg, South Carolina, 29307, United States
Baptist Memorial Hospital Memphis | Memphis, Tennessee, United States
The West Cancer Clinic | Memphis, Tennessee, United States
Northwest Texas Healthcare System | Amarillo, Texas, 79106, United States
The Methodist Hospital | Houston, Texas, 77030, United States
Scott & White Memorial Hospital & Clinic | Temple, Texas, 76508, United States
The University of Texas Health Center at Tyler | Tyler, Texas, 75708, United States
University Hospital | Salt Lake City, Utah, United States
Inova Alexandria Hospital | Alexandria, Virginia, 22304, United States
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, 23249, United States
Swedish Medical Center | Seattle, Washington, 98122, United States
Sacred Heart Medical Center | Spokane, Washington, 99220, United States
| Buenos Aires, Argentina
| Box Hill, Clayton, Garran, Kogarah, Ringwood East, Australia
| St. Leonards, South Australia, Australia
| Graz, Austria
| Bruxelles, Charleroi, Leuven, Liege, Yvoir, Belgium
| Goiania, Porto Alegre, Sao Paulo, Salvador, Brazil
University of Alberta Hospital | Edmonton, Alberta, T6G 2B7, Canada
Kelowna General Hospital | Kelowna, British Columbia, V1Y 1T2, Canada
St. Paul's Hospital | Vancouver, British Columbia, Canada
St. Boniface General Hospital | Winnipeg, Manitoba, R2H 2A6, Canada
QEII Health Sciences Center | Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton Health Sciences - General Hospital | Hamilton, Ontario, Canada
London Health Sciences Centre | London, Ontario, N6A 4G5, Canada
Ottawa Hospital - Civic Campus | Ottawa, Ontario, K1Y 4E9, Canada
University Health Network, Toronto General Hospital | Toronto, Ontario, Canada
Humber River Regional Hospital | Weston, Ontario, Canada
Jewish General Hospital | Montreal, Quebec, Canada
Hotel-Dieu de St-Jerome | St-Jerome, Quebec, Canada
| Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague, Czech Republic
| Plzen, Czech Republic
| Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense, Denmark
| Roskilde, Denmark
| Hus, Jyvaskyla, Seinajoki, Turku, Finland
| Armentieres, Besancon, Bethune, Brest, Chambray Les Tours, France
| Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix, France
| Saint Malo, Valenciennes, France
| Tourcoing, France
| Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen, Germany
| Heidelberg, Ibbenburen, Mannheim, Munchen, Germany
| Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia, Italy
| Piacenza, Pisa, Reggio Emilia, Treviso, Venezia, Italy
| Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen, Netherlands
| Haarlem, Maastricht, Nieuwegein, Netherlands
| Oslo, Rud, Norway
| Lublin, Warszawa, Wroclaw, Poland
| Badalona, Madrid, Sevilla, Spain
| Goteborg, Jonkoping, Stockholm, Varnamo, Sweden
| Basel, Bern, Lugano, Switzerland
| London, United Kingdom
Standort Länder

Argentina

Australia

Austria

Belgium

Brazil

Canada

Czech Republic

Denmark

Finland

France

Germany

Italy

Netherlands

Norway

Poland

Spain

Sweden

Switzerland

United Kingdom

United States

Überprüfungsdatum

April 2009

Verantwortliche Partei

Nenne den Titel: ICD Study Director

Organisation: sanofi-aventis

Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov