Back to resultsDirect Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM150
warfarin
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Factor Xa inhibitor, Atrial fibrillation, Stroke, Ischemic attack, thromboembolism, Prevention and control
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
Low dose
Middle dose
High dose
Outcomes
Primary Outcome Measures
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
Secondary Outcome Measures
Incidence of symptomatic stroke
Incidence of transient ischemic attack (TIA)
Incidence of systemic thromboembolic event
Incidence of the bleeding rates
Other safety assessments
PK, PD variables
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00448214
Brief Title
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
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 Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Factor Xa inhibitor, Atrial fibrillation, Stroke, Ischemic attack, thromboembolism, Prevention and control
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
448 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low dose
Arm Title
2
Arm Type
Experimental
Arm Description
Middle dose
Arm Title
3
Arm Type
Experimental
Arm Description
High dose
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
warfarin
Intervention Description
Oral
Primary Outcome Measure Information:
Title
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Incidence of symptomatic stroke
Time Frame
16 Weeks
Title
Incidence of transient ischemic attack (TIA)
Time Frame
16 Weeks
Title
Incidence of systemic thromboembolic event
Time Frame
16 Weeks
Title
Incidence of the bleeding rates
Time Frame
16 Weeks
Title
Other safety assessments
Time Frame
16 Weeks
Title
PK, PD variables
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Launceston
Country
Australia
City
Pok Fu Lam
Country
Hong Kong
City
Sha Tin
Country
Hong Kong
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kanto
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
City
Tohoku
Country
Japan
City
Seoul
Country
Korea, Republic of
City
kuala Lumpur
Country
Malaysia
City
Hastings
Country
New Zealand
City
Singapore
Country
Singapore
City
Bloemfontein
Country
South Africa
City
Taipei
Country
Taiwan
City
Bangkok
Country
Thailand
City
Chiang Mai
Country
Thailand
City
Nakhon Ratchasima
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
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