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SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
This study has been completed.
First Received: October 16, 2003   Last Updated: April 28, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00071279
  Purpose

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.


Condition Intervention Phase
Pulmonary Embolism
Deep Vein Thrombosis
Drug: SR34006 (idraparinux sodium) Injection
Phase III

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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Symptomatic recurrent PE/DVT during the 6-month study treatment period.

Secondary Outcome Measures:
  • Major bleeding during the 6-month study treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071279

  Show 65 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Additional Information:
No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC5135, SR34006
Study First Received: October 16, 2003
Last Updated: April 28, 2009
ClinicalTrials.gov Identifier: NCT00071279     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Pulmonary Embolism
Naphthoquinone
Vascular Diseases
Phylloquinone
Venous Thromboembolism
Thrombosis
Thromboembolism
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Vitamins
Vitamin K
Menadione
Menaquinone
Venous Thrombosis

Additional relevant MeSH terms:
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on September 03, 2009