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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00448214
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : December 19, 2011
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: YM150 Drug: warfarin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Low dose
Drug: YM150

Experimental: 2
Middle dose
Drug: YM150

Experimental: 3
High dose
Drug: YM150

Active Comparator: 4 Drug: warfarin

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

Secondary Outcome Measures :
  1. Incidence of symptomatic stroke [ Time Frame: 16 Weeks ]
  2. Incidence of transient ischemic attack (TIA) [ Time Frame: 16 Weeks ]
  3. Incidence of systemic thromboembolic event [ Time Frame: 16 Weeks ]
  4. Incidence of the bleeding rates [ Time Frame: 16 Weeks ]
  5. Other safety assessments [ Time Frame: 16 Weeks ]
  6. PK, PD variables [ Time Frame: 16 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00448214

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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
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Study Chair: Central Contact Astellas Pharma Inc
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Responsible Party: Astellas Pharma Inc Identifier: NCT00448214    
Other Study ID Numbers: 150-CL-030
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: December 2011
Keywords provided by Astellas Pharma Inc:
Factor Xa inhibitor
Atrial fibrillation
Ischemic attack
Prevention and control
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes