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

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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 Warfarin sodium

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 ]

Enrollment:	18199
Study Start Date:	December 2006
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: warfarin Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0) Other Names: Coumadin BMS-565793
Experimental: 2	Drug: apixaban Oral tablets, 5.0 mg, twice daily Other Name: BMS-562247

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

Show 1012 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 by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. Epub 2011 Aug 27.

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00412984 History of Changes
Other Study ID Numbers:	CV185-030
Study First Received:	December 18, 2006
Last Updated:	November 29, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012