Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
NCT ID: NCT00448214
Last Updated: 2011-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
448 participants
INTERVENTIONAL
2007-03-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Low dose
YM150
Oral
2
Middle dose
YM150
Oral
3
High dose
YM150
Oral
4
warfarin
Oral
Interventions
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YM150
Oral
warfarin
Oral
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Launceston, , Australia
Pok Fu Lam, , Hong Kong
Shatin, , Hong Kong
Hokkaido, , Japan
Kansai, , Japan
Kanto, , Japan
Kyusyu, , Japan
Shikoku, , Japan
Tōhoku, , Japan
Kuala Lumpur, , Malaysia
Hastings, , New Zealand
Singapore, , Singapore
Bloemfontein, , South Africa
Seoul, , South Korea
Taipei, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Nakhon Ratchasima, , Thailand
Countries
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Other Identifiers
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150-CL-030
Identifier Type: -
Identifier Source: org_study_id