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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Darexaban; Factor Xa Inhibitors; Warfarin

Criteria

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.