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

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