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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00448214

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 II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium Antithrombin III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	450
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Low dose	Drug: YM150 Oral
2: Experimental Middle dose	Drug: YM150 Oral
3: Experimental High dose	Drug: YM150 Oral
4: Active Comparator	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

Sha Tin, Hong Kong

Pok Fu Lam, Hong Kong
Japan

Hokkaido, Japan

Kyusyu, Japan

Kanto, Japan

Kansai, 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

Nakhon Ratchasima, Thailand

Chiang Mai, Thailand

Bangkok, Thailand

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma, Inc. ( Director )
Study ID Numbers:	150-CL-030
Study First Received:	March 15, 2007
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00448214
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

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Cerebral Infarction
Stroke
Warfarin

Ischemia
Atrial Fibrillation
Antithrombin III
Thromboembolism
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009