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”

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.

Study Type: Interventional

Study Design: Randomized, Double-Blind, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: SR34006 (idraparinux sodium) Injection

Primary Measures

• Symptomatic recurrent PE/DVT during the 6-month study treatment period.

Secondary Measures

• Major bleeding during the 6-month study treatment period.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00071279

Study ID Number: EFC5135

ClinicalTrials.gov Identifier: NCT00071279

Health Authority: United States: Food and Drug Administration