Please select the eligibility criteria that correspond to the clinical trial below.
Title: Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.
Brief Summary: The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.


Options:
A: Inclusion Criteria:

* Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis involving at least the upper third part of the calf veins, without concomitant symptomatic PE
* 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 DVT
* Other indication for VKA than PE/DVT
* More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \< 30 mL/min, impaired liver function (transaminases \> 2 x ULN), or bacterial endocarditis
* Life expectancy \< 3 months
* Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin
* Uncontrolled hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 110 mmHg
* Pregnancy or childbearing potential without proper contraceptive measures
* Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin
* Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study
B: Inclusion Criteria:

* A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.
* A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
* If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

* A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
* A person who has active internal bleeding or has a history of a bleeding disorder.
* Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
* A person who has liver disease; for example, cirrhosis.
* A person who has a condition such as alcoholism, mental illness, or is drug dependent.
* A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).
C: Inclusion Criteria:

* Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.
* Evidence of high risk of vascular events: at least one of the following risk criteria must be present:

  * are 75 years or greater;
  * on treatment for systemic hypertension;
  * prior stroke, TIA, or non-CNS systemic embolus;
  * left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be \< 45%;
  * peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio \< 0.9);
  * age 55 to 74 years; AND
  * either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.

Exclusion Criteria:

* Patients will be excluded from ACTIVE if any of the following are present :

  * requirement for clopidogrel (such as recent coronary stent procedure);
  * requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
  * prior intolerance to ASA or clopidogrel;
  * documented peptic ulcer disease within the previous 6 months;
  * prior intracerebral hemorrhage;
  * significant thrombocytopenia; (platelet count \< 50 x 10(9)/L);
  * psychosocial reason making study participation impractical;
  * geographic reason making study participation impractical;
  * ongoing alcohol abuse;
  * mitral stenosis;
  * pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study;
  * severe comorbid condition such that the patient is not expected to survive 6 months;
  * patient currently receiving an investigational pharmacologic agent; OR
  * requirement for chronic (\> 3 months) non-COX-2 inhibitor NSAID therapy.
D: Inclusion Criteria:

* Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome.
* Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
* At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
* Written informed consent

Exclusion Criteria:

* Age \< 21 years
* Any contraindication to low molecular weight heparin
* Hemorrhagic stroke within the last 12 months
* Indication for anticoagulation other than ACS.
* Pregnancy or women of childbearing potential who are not using an effective method of contraception
* Co-morbid condition with life expectancy less than 6 months
* Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent

Answer: A