SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071279
• Other study ID #: EFC5135
• Secondary ID: SR34006
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2003
• Last updated: April 5, 2011
• Start date: November 2003
• Est. completion date: December 2005

Study information

• Verified date: April 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• SR34006 (idraparinux sodium) Injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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, 

Outcome

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.

External Links

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