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NCT Number: NCT00062803

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SR34006

Drug

(LMW)heparin

Drug

Warfarin VKA

Drug

Acenocoumarol VKA

Drug

Primary outcomes

  1. symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Secondary outcomes

  1. symptomatic recurrent PE/DVT within 6 months.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jun 17, 2003
Registry last updated
Apr 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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