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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00448214
First received: March 15, 2007
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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
Oral
Experimental: 2
Middle dose
 Drug: YM150
Oral
Experimental: 3
High dose
 Drug: YM150
Oral
Active Comparator: 4 Drug: warfarin
Oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448214

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov 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
Stroke
 Ischemic attack
thromboembolism
Prevention and control

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013