Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis
Brief Summary: Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.


Options:
A: 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.
B: Inclusion Criteria:

* Subjects with a confirmed diagnosis (by Multi detector-row CT \[MDCT\]) of acute symptomatic PE who are hemodynamically stable (i.e., the condition where anticoagulant therapy alone are indicated) (the time from onset should be no longer than 5 days, and subjects with or without symptomatic DVT are eligible)
* Age: \>=20 years
* Gender: No restriction Female subjects must either be of non-childbearing potential (post-menopausal \>1 year, hysterectomy, or sterilization), or of childbearing potential, has a negative pregnancy test at screening, and agree to use contraception throughout the study period.
* Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period.
* Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent.

Exclusion Criteria:

* Shock or hemodynamic instability\*.

  \*: Defined as shock or decreased blood pressure (systolic blood pressure \<90 mmHg or \>=40 mmHg) lasting for at least 15 minutes and does not represent hemodynamically unstable conditions due to newly emergent arrhythmia, dehydration or sepsis.
* Right cardiac function failure detected by echocardiography at screening.
* Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current PE.
* Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present.
* Prior to entry into the study, therapeutic dosage of anticoagulants for more than 24 hours to treat the current episode.
* Active, clinically significant bleeding
* Thrombocytopenia (platelet count \<10×10⁴/µL at screening)
* Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension\*, or severe diabetes) or bleeding tendency.

  \*: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
* Severe hepatic disorder
* Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
* Previous history of cerebral hemorrhage
* Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
* Previous history of Heparin-induced thrombocytopenia
* Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant).
* Severe renal disorder (serum creatinine \>2.0 mg/dL \[180 µmol/L\] at screening) in a well hydrated subject
* Documented hypersensitivity to contrast media
* Use of any contraindicated drug that cannot be combined with the injection of contrast medium \[e.g., antihyperglycemic metformin hydrochloride (Glycoran®, Melbin®)\]
* Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
* Previous participation in a study of GSK576428
* Drug or alcohol abuse
* Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
* Recent surgery within 3 days prior to entry into the study
* Life expectancy \<3 months
* Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
* Others whom the investigator or subinvestigator considers not eligible for the study
C: Inclusion Criteria:

* Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis

Exclusion Criteria:

* End stage renal failure, hepatic failure, uncontrolled hypertension;
* Active bleeding or high risk for bleeding;
* Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion.
* Breastfeeding.
* Known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins;
* hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin;
* Indication of prolonged anticoagulation therapy for other reason than PE;
* Life expectancy \< 6 months;
D: Inclusion Criteria:

* age at least 18 years
* undergoing first ever multivessel CABG-only surgery with at least 2 free grafts (e.g. Radial artery, saphenous vein, free internal mammary artery)
* undergoing CABG with cardiopulmonary bypass

Exclusion Criteria:

* clear indication for anticoagulation (e.g. prosthetic heart valve replacement, recurrent DVT)
* allergy or intolerance of fondaparinux or unfractionated heparin
* renal failure or other contraindication for coronary artery graft CT angiogram
* inability to provide informed consent

Answer: C