Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

This study is ongoing, but not recruiting participants.

First Received: June 29, 2007 Last Updated: April 8, 2009 History of Changes

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:	NCT00494871

Purpose

This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

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

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

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Rivaroxaban Warfarin sodium Warfarin potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Efficacy and Safety of Rivaroxaban (BAY 59-7939) 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:

(Safety)The composite of major and non-major clinically relevant bleeding events [ Time Frame: Throughout treatment and followup period ] [ Designated as safety issue: Yes ]
(Efficacy)The composite of stroke and non-CNS systemic embolism [ Time Frame: Throughout treatment and followup period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Each category of bleeding events, and adverse event [ Time Frame: Throughout treatment and followup period ] [ Designated as safety issue: Yes ]
The composite of stroke, non-CNS systemic embolism, and vascular death [ Time Frame: Throughout treatment and followup period ] [ Designated as safety issue: No ]

Enrollment:	1280
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) BAY 59-7939 10mg OD:creatinine clearance 30 to 49mL/min
Arm 2: Active Comparator	Drug: Warfarin Dose-adjusted warfarin based on target INR values

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

20 years or older
Japanese male or female
Non- valvular atrial fibrillation documented by ECG
Patients with a risk of stroke and non-CNS systemic embolism

Exclusion Criteria:

Significant mitral stenosis
Patients in whom anticoagulants are contraindicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494871

Show 164 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

Additional Information:

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No publications provided

Responsible Party:	Bayer Yakuhin Ltd. ( Therapeutic Area Head )
Study ID Numbers:	12620
Study First Received:	June 29, 2007
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00494871 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:

BAY 59-7939
Rivaroxaban
Non-Valvular Atrial Fibrillation

Japanese Patients
Phase III
12620

Study placed in the following topic categories:

Anticoagulants
Heart Diseases
Cerebral Infarction
Embolism

Stroke
Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Heart Diseases
Therapeutic Uses
Hematologic Agents

Cardiovascular Diseases
Warfarin
Atrial Fibrillation
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009