Randomized, Double-Blind Study Comparing Once Daily Oral Rivaroxaban With Adjusted-Dose Oral Warfarin for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - Full Text View

Sponsors and Collaborators:	Bayer Johnson & Johnson Pharmaceutical Research & Development, L.L.C. - within the U.S., Johnson&Johnson is sponsor
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00403767

Purpose

The purpose of this study is to demonstrate that the efficacy and safety of 20 mg once daily rivaroxaban in preventing thromboembolic events in subjects with atrial fibrillation not related to mitral valve stenosis. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive) will receive a dose adaptation to rivaroxaban 15 mg once daily.

Condition	Intervention	Phase
Atrial Fibrillation Stroke	Drug: Rivaroxaban (BAY59-7939) Drug: Warfarin	Phase III

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 Rivaroxaban

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:	A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

Further study details as provided by Bayer:

Primary Outcome Measures:

Composite of major and non-major clinically relevant bleeding events [ Time Frame: 1 day up to 4 years ] [ Designated as safety issue: No ]
Any stroke or non-CNS systemic embolism. [ Time Frame: 1 day up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Each category of bleeding events, and adverse events [ Time Frame: 1 day up to 4 years ] [ Designated as safety issue: Yes ]
Composite of stroke, non-CNS systemic embolism, and vascular death [ Time Frame: 1 day up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	14000
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Warfarin Warfarin p.o. once daily titrated to a target INR of 2.5 (range 2.0 to 3.0, inclusive)
Arm 2: Experimental	Drug: Rivaroxaban (BAY59-7939) Rivaroxaban 20mg p.o. once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients 18 years of age or older
Subjects must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, OR at least two of the following risk factors:
Heart failure
Hypertension
Age 75 years or greater
Diabetes mellitus

Exclusion Criteria:

Significant mitral stenosis
Transient atrial fibrillation caused by a reversible disorder
Active internal bleeding
Severe disabling stroke
History of intracranial bleeding
Hemorrhagic disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403767

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list), if you still have questions:		info1@veritasmedicine.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937	clinical-trials-contact@bayerhealthcare.com

Show 1161 Study Locations

Sponsors and Collaborators

Bayer

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

- within the U.S., Johnson&Johnson is sponsor

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	11630, EudraCT No.: 2006-004595-13
Study First Received:	November 23, 2006
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00403767
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Cerebral Infarction
Embolism
Stroke
Vascular Diseases
Central Nervous System Diseases

Warfarin
Atrial Fibrillation
Brain Diseases
Cerebrovascular Disorders
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Therapeutic Uses
Hematologic Agents

Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009