Clinical trial NCT00071279: SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
Official title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-10-20
Enrollment: 1215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
* Written informed consent

Exclusion Criteria:

* Legal age limitations (country specific)
* Indication for anticoagulation other than PE or DVT
* Creatinine clearance (CLcr) \<10 mL/min, severe hepatic disease, or bacterial endocarditis
* Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
* Life expectancy \<3 months
* Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 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, women who are breastfeeding.

Primary outcomes:
measure: Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Secondary outcomes:
measure: Major bleeding during the 6-month study treatment period.
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VA Medical Center
state: Florida
city: Brandon
country: United States
facility: Pulmonary Associates of Brandon
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Cardiovascular Clinic
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates (MIMA)
state: Florida
city: Palm Bay
country: United States
facility: Melbourne Internal Medical Associates (MIMA)
state: Florida
city: Tampa
country: United States
facility: Clinical Pharmacology Services
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Bloomfield Hills
country: United States
facility: Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy - Oakland Clinical Research Office
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy - Oakland
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital / Clinical Research Center
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital Troy
state: Michigan
city: Albuquerque
country: United States
facility: Lovelace Sandia Health Systems, Clinical Thrombosis Center
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Upland
country: United States
facility: Crozer-Chester Medical Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Lung & Chest Medical Associates
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Pharmaceutical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial Hospital and Clinic
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Center at Tyler
state: Texas
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Fredericksburg
country: United States
facility: Pulmonary Associates of Fredericksburg, Inc.
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Pulmonary Specialists/Spokane Respiratory Consultants
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
country: Australia
city: Premantle, Redcliffe, St. Leonards, South Australia
country: Australia
city: Ringwood East, Woolloongabba
country: Australia
city: Graz, Wien
country: Austria
city: Bruxelles, Duffel, Leuven, Lier, Zottegem
country: Belgium
city: Porto Alegre, Salvador, Sao Paulo
country: Brazil
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Civic Campus
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sainte-Foy
country: Canada
facility: Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec
state: Quebec
city: Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno
country: Czech Republic
city: Ostrava-Poruba, Plzen, Prague, Usti nad Labem
country: Czech Republic
city: Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod
country: Denmark
city: Kobenhavn, Odense
country: Denmark
city: Seinajoki
country: Finland
city: Besancon, Brest, Chambray les Tours, Clamart, Grenoble
country: France
city: Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne
country: France
city: Toulouse, Valenciennes
country: France
city: Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim
country: Germany
city: Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia
country: Italy
city: Treviso, Venezia
country: Italy
city: Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem
country: Netherlands
city: Maastricht, Nieuwegein, Sittard, Zwolle
country: Netherlands
city: Auckland
country: New Zealand
city: Oslo, Rud
country: Norway
city: Bialystok, Szczecin, Warszawa, Wroclaw
country: Poland
city: Bloemfontein, Bryanston, Durban
country: South Africa
city: Barcelona, Madrid, Torrelavega, Xativa
country: Spain
city: Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik
country: Sweden
city: London
country: United Kingdom
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12. doi: 10.1056/NEJMoa067703.