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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: SR34006
* Drug: (LMW)heparin
* Drug: Warfarin VKA
* Drug: Acenocoumarol VKA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SR34006|nan|
|Drug: (LMW)heparin|nan|
|Drug: Warfarin VKA|nan|
|Drug: Acenocoumarol VKA|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic recurrent PE/DVT within 6 months. |  |  |