Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
- Registration Number
- NCT00448214
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 448
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 YM150 High dose 4 warfarin - 1 YM150 Low dose 2 YM150 Middle dose
- Primary Outcome Measures
Name Time Method All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)" 16 Weeks
- Secondary Outcome Measures
Name Time Method Incidence of symptomatic stroke 16 Weeks Incidence of transient ischemic attack (TIA) 16 Weeks Incidence of systemic thromboembolic event 16 Weeks Incidence of the bleeding rates 16 Weeks Other safety assessments 16 Weeks PK, PD variables 16 Weeks