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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448214

Enrollment

448

Registered

2007-03-16

Start date

2007-03-31

Completion date

2008-10-31

Last updated

2011-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Factor Xa inhibitor, Atrial fibrillation, Stroke, Ischemic attack, thromboembolism, Prevention and control

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

Interventions

DRUGYM150

Oral

DRUGwarfarin

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
All clinically relevant bleeds during the treatment period rated as major or clinically relevant non-major(CRNM)	16 Weeks

Secondary

Measure	Time frame
Incidence of transient ischemic attack (TIA)	16 Weeks
Incidence of systemic thromboembolic event	16 Weeks
Incidence of symptomatic stroke	16 Weeks
Other safety assessments	16 Weeks
PK, PD variables	16 Weeks
Incidence of the bleeding rates	16 Weeks

Countries

Australia, Hong Kong, Japan, Malaysia, New Zealand, Singapore, South Africa, South Korea, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026