Pulmonary Embolism Clinical Trial
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
Verified date | April 2011 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1215 |
Est. completion date | December 2005 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | Kelowna General Hospital | Kelowna | British Columbia |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | The Ottawa Hospital, Civic Campus | Ottawa | Ontario |
Canada | Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec | Sainte-Foy | Quebec |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
United States | Lovelace Sandia Health Systems, Clinical Thrombosis Center | Albuquerque | New Mexico |
United States | University of New Mexico Hospital | Albuquerque | New Mexico |
United States | Inova Alexandria Hospital | Alexandria | Virginia |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Medical College of Georgia | Augusta | Georgia |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Bay Pines VA Medical Center | Bay Pines | Florida |
United States | Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office | Bloomfield Hills | Michigan |
United States | Pulmonary Associates of Brandon | Brandon | Florida |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Pulmonary Associates of Fredericksburg, Inc. | Fredericksburg | Virginia |
United States | The Methodist Hospital | Houston | Texas |
United States | Jacksonville Cardiovascular Clinic | Jacksonville | Florida |
United States | Cardinal Bernardin Cancer Center | Maywood | Illinois |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Melbourne Internal Medicine Associates (MIMA) | Melbourne | Florida |
United States | Melbourne Internal Medical Associates (MIMA) | Palm Bay | Florida |
United States | St. Joseph Mercy - Oakland | Pontiac | Michigan |
United States | St. Joseph Mercy - Oakland Clinical Research Office | Pontiac | Michigan |
United States | McGuire VA Medical Center | Richmond | Virginia |
United States | William Beaumont Hospital / Clinical Research Center | Royal Oak | Michigan |
United States | Swedish Medical Center | Seattle | Washington |
United States | Lung & Chest Medical Associates | Spartanburg | South Carolina |
United States | Spartanburg Pharmaceutical Research | Spartanburg | South Carolina |
United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Pulmonary Specialists/Spokane Respiratory Consultants | Spokane | Washington |
United States | Sacred Heart Medical Center | Spokane | Washington |
United States | Clinical Pharmacology Services | Tampa | Florida |
United States | Scott and White Memorial Hospital and Clinic | Temple | Texas |
United States | William Beaumont Hospital Troy | Troy | Michigan |
United States | The University of Texas Health Center at Tyler | Tyler | Texas |
United States | Crozer-Chester Medical Center | Upland | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptomatic recurrent PE/DVT during the 6-month study treatment period. | |||
Secondary | Major bleeding during the 6-month study treatment period. |
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