SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
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.
|Pulmonary Embolism||Drug: SR34006 Drug: (LMW)heparin Drug: Warfarin VKA Drug: Acenocoumarol VKA||Phase 3|
|Study Design:||Allocation: Randomized
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|
- symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
- 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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062803
Show 93 Study Locations
|Study Director:||ICD CSD||Sanofi|