Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin

To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population

Inclusion Criteria:

Subjects are eligible for the study if all of the following apply:

• Subject has paroxysmal permanent or persistent NVAF
• Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
• Legal minimum age requirement (country-specific).
• Written informed consent has been obtained.

Exclusion Criteria:

• History of heart valve disorders
• History of rheumatic fever.
• History of stroke and/or systemic embolism (including TIA).
• History of Acute Coronary Syndrome (ACS).
• Indication for warfarin other than NVAF.
• Known hemorrhagic disorder and/or coagulation disorder.
• Active bleeding or any condition associated with increased risk of bleeding.