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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: March 15, 2007
Last updated: December 15, 2011
Last verified: December 2011
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

Condition Intervention Phase
Atrial Fibrillation
Drug: YM150
Drug: warfarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)" [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of symptomatic stroke [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of transient ischemic attack (TIA) [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of systemic thromboembolic event [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of the bleeding rates [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • Other safety assessments [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • PK, PD variables [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Enrollment: 448
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low dose
Drug: YM150
Experimental: 2
Middle dose
Drug: YM150
Experimental: 3
High dose
Drug: YM150
Active Comparator: 4 Drug: warfarin


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00448214

Launceston, Australia
Hong Kong
Pok Fu Lam, Hong Kong
Sha Tin, Hong Kong
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Shikoku, Japan
Tohoku, Japan
Korea, Republic of
Seoul, Korea, Republic of
kuala Lumpur, Malaysia
New Zealand
Hastings, New Zealand
Singapore, Singapore
South Africa
Bloemfontein, South Africa
Taipei, Taiwan
Bangkok, Thailand
Chiang Mai, Thailand
Nakhon Ratchasima, Thailand
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc Identifier: NCT00448214     History of Changes
Other Study ID Numbers: 150-CL-030 
Study First Received: March 15, 2007
Last Updated: December 15, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
Taiwan: Department of Health
Hong Kong: Department of Health
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Health Research Council
Malaysia: Ministry of Health
South Africa: Department of Health

Keywords provided by Astellas Pharma Inc:
Factor Xa inhibitor
Atrial fibrillation
Ischemic attack
Prevention and control

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Factor Xa Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Serine Proteinase Inhibitors processed this record on May 26, 2016