Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
Brief Summary: Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.


Options:
A: 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
B: Inclusion Criteria:

* Non valvular atrial fibrillation (AF)
* Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age \> or = 75 years, diabetes mellitus.

Main exclusion Criteria:

* Indication for VKA other than AF
* Stroke or TIA within previous 5 days
* Transient AF caused by a reversible disorder
* Planned major surgery/trauma or cardioversion within 30 days
* INR \> 3 at baseline
* Active bleeding or high risk of bleeding
* Uncontrolled hypertension
* Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.
C: Inclusion Criteria:

* Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
* Written informed consent

Exclusion Criteria:

* Legal age limitations (country specific)
* Indication for anticoagulation other than PE or DVT
* Creatinine clearance (CLcr) \<10 mL/min, severe hepatic disease, or bacterial endocarditis
* Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
* Life expectancy \<3 months
* Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 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, women who are breastfeeding.
D: Inclusion Criteria:

* Confirmed acute symptomatic DVT
* Written informed consent

Exclusion Criteria:

* Legal lower age limitations
* Patients with symptomatic pulmonary embolism
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
* Other indication for VKA than DVT
* More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \<10mL/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 and diastolic blood pressure \>110 mm Hg.
* Pregnancy or childbearing potential without proper contraceptive measures
* Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin

Answer: C