Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation
Brief Summary: The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.


Options:
A: Inclusion Criteria:

* Males and females ≥ 18 yrs with atrial fibrillation (AF) and one or more of the following risk factors for stroke:
* Age ≥ 75, previous stroke
* transient ischemic attack (TIA) or Systemic Embolism (SE)
* Symptomatic congestive heart failure or left ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40%
* Diabetes mellitus or hypertension requiring pharmacological treatment
B: Inclusion Criteria:

* 21 years of age or older; male or female.
* Able to provide written informed consent.
* History of documented AF within the prior 12 months
* A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion Criteria:

* Transient atrial fibrillation secondary to other reversible disorders
* Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
* Subjects with any contraindication for anticoagulant agents;
* Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
* Females of childbearing potential including the following:

  * Females with a history of tubal-ligation
  * Females less than 2 years post-menopausal
C: Inclusion Criteria:

* Age ≥ 20 years outpatient (regardless of sex)
* Patients diagnosed as non-valvular atrial fibrillation (NVAF)
* One or more following risks of stroke.

Exclusion Criteria:

* Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
* Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
* Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
D: Inclusion Criteria:

* Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
* Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit

Exclusion Criteria:

* Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
* Subject has active bleeding or any condition associated with increased risk of bleeding
* Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
* Subject has an indication for warfarin other than AF (including planned cardioversion)
* Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
* Subject has a diagnosis of left ventricular aneurysm or atrial myxoma
* Subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics \[such as tissue Plasminogen Activator (tPA), streptokinase\], antiplatelet agents \[such as cilostazol, clopidogrel, ticlopidine, dipyridamole\], anticoagulants \[such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors\] and chronic use of nonsteroidal anti-inflammatory drugs \[NSAIDs\] or acetylsalicylic acid use of \>100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
* Subject has active infective endocarditis
* Subject is planned for invasive procedures with potential for bleeding
* Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
* Subject has participated in any YM150 clinical trials

Answer: A