Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation - Full Text View

Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE)

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, October 2009

First Received: December 18, 2006 Last Updated: February 3, 2010 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00412984

Purpose

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Condition	Intervention	Phase
Atrial Fibrillation Atrial Flutter	Drug: warfarin Drug: apixaban	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

Resource links provided by NLM:

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 Apixaban Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

confirmed stroke or systemic embolism [ Time Frame: Time to first occurrence ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

confirmed ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death [ Time Frame: Time to first occurrence ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18183
Study Start Date:	December 2006
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: warfarin Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
2: Experimental	Drug: apixaban Oral tablets, 5.0 mg, twice daily

Eligibility

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

Criteria

Inclusion Criteria:

Males and females ≥ 18 yrs with AF and one or more of the following risk factors for stroke:
Age ≥ 75, previous stroke
TIA or Systemic Embolism
Symptomatic congestive heart failure or left ventricular dysfunction with LVEF ≤ 40%
Diabetes mellitus or hypertension requiring pharmacological treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412984

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 1084 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV185-030
Study First Received:	December 18, 2006
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00412984 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Heart Diseases
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases

Warfarin
Atrial Fibrillation
Pharmacologic Actions
Atrial Flutter
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010