Please select the eligibility criteria that correspond to the clinical trial below.
Title: Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
Brief Summary: The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).


Options:
A: Inclusion criteria

1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation

Exclusion criteria

1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy
5. Patients who in the investigators opinion should not be treated with warfarin
6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
8. Known anaemia
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease
11. Elevated AST or ALT \> 2x ULN
12. Liver disease expected to have any potential impact on survival
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment
15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator
B: Inclusion criteria:

1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.
2. Written informed consent

Exclusion criteria:

1. Younger then 18 years of age
2. Indication for VKA other than DVT and/or PE
3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT \> 3 x ULN
5. Creatinine clearance \< 30 ml/min
6. Acute bacterial endocarditis
7. Active bleeding or high risk for bleeding.
8. Uncontrolled hypertension (investigators judgement)
9. Intake of another experimental drug within the 30 days prior to randomization into the study
10. Life expectancy \<6 months
11. Childbearing potential without proper contraceptive measures\*, pregnancy or breast feeding
C: Inclusion Criteria:

* Age \> 18 years
* Social security affiliation
* Written informed consent
* Solid active cancer, high grade lymphoma or myeloma treated with Immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide). Active cancer is defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy or targeted therapy at inclusion.
* Histologically or cytologically proven cancer.
* Symptomatic venous thromboembolism objectively confirmed diagnosed because of symptoms or discovered incidentally
* High-risk of recurrent Venous thromboembolism (VTE) defined by a score of 0 or ≥ 1, using the following criteria: female sex (+1), lung cancer (+1), breast cancer (-1) non metastatic tumor (-2), previous VTE (+1).

Exclusion Criteria:

* Exclusive adjuvant hormonal treatment with no measurable residual disease
* Sub-segmental isolated pulmonary embolism (PE) without associated proximal DVT
* Isolated distal deep vein thrombosis (DVT) of the legs
* Isolated upper-extremity DVT or superior vena cava thrombosis
* Isolated visceral thrombosis
* Platelet count \< 50 000 G/L
* Active bleeding
* Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
* Hemostatic defect with contraindication to anticoagulant treatment at therapeutic dosage
* Vena cava filter at inclusion
* Fibrinolytic therapy within 3 days preceding inclusion
* Creatinine clearance \< 30 ml/min according to Cockcroft-Gault formula
* Previous heparin-induced thrombocytopenia
* Anticoagulant treatment at curative dosage for more than 3 days before inclusion
* Pregnancy or lack of effective contraceptive treatment for women of childbearing age
* Treatment with both strong CYP3A4 and P-glycoprotein (PgP) inhibitors: protease inhibitors for HIV disease, systemic ketoconazole
* Treatment with a strong CYP3A4 inducer: rifampicin, carbamazepine, phenytoin.
* Life expectancy \< 3 months
* Eastern Cooperative Oncology Group (ECOG) level 3 or 4
D: Inclusion Criteria:

* Men and women \>/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)

Exclusion Criteria:

* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
* More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization
* Calculated creatinine clearance (CLCR) \< 30 mL/min
* Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
* Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
* Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg

Answer: B