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SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00062803
First received: June 16, 2003
Last updated: April 28, 2009
Last verified: April 2009
History of Changes
  Purpose

Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.


Condition Intervention Phase
Pulmonary Embolism
 Drug: SR34006
Drug: (LMW)heparin
Drug: Warfarin VKA
Drug: Acenocoumarol VKA
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Secondary Outcome Measures:
  • symptomatic recurrent PE/DVT within 6 months.

Study Start Date: June 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
  • Written informed consent

Exclusion Criteria:

  • Legal lower age limitations (country specific)
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
  • Other indication for VKA than PE/DVT
  • More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization
  • Participation in another pharmacotherapeutic study within the prior 30 days
  • Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis
  • Life expectancy <3 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 or women who are breastfeeding
  • Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin, enoxaparin, or tinzaparin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062803

  Show 93 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00062803     History of Changes
Other Study ID Numbers: EFC3484
Study First Received: June 16, 2003
Last Updated: April 28, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Acenocoumarol
Heparin
Warfarin
Vitamin K
Vitamins
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on May 16, 2013