Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
ORBIT-AF II
2 other identifiers
observational
13,769
3 countries
219
Brief Summary
The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Longer than P75 for all trials
219 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedStudy Start
First participant enrolled
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2017
CompletedFebruary 3, 2025
January 1, 2025
4.4 years
October 3, 2012
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of major bleeding events
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
2 years
Secondary Outcomes (1)
Number of major adverse cardiac events
2 years
Study Arms (1)
Patients with Atrial Fibrillation (AF)
(1) patients with new onset/first detected Atrial Fibrillation (AF) diagnosed within the 6 months preceding the baseline visit; or (2) patients with AF who had initiation or transition to a FXa (Factor Xa) inhibitor or a direct thrombin inhibitor within the preceding 3 months.
Interventions
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
Eligibility Criteria
Enrolling physicians will include cardiologists, internists, and electrophysiologists from both academic and private practice who preferably have experience in registry participation.
You may not qualify if:
- Atrial flutter only - Anticipated life expectancy less than 6 months - short lasting AF secondary to a reversible condition (e.g. hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery) - Participation in a randomized trial of anticoagulation for AF at the time of enrollment - Was enrolled in the ORBIT-I Registry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Scientific Affairs, LLClead
- Duke Clinical Research Institutecollaborator
- Bayercollaborator
Study Sites (219)
Unknown Facility
Cullman, Alabama, United States
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Dothan, Alabama, United States
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Fairhope, Alabama, United States
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Mobile, Alabama, United States
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Tuscaloosa, Alabama, United States
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Avondale, Arizona, United States
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Glendale, Arizona, United States
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Goodyear, Arizona, United States
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Scottsdale, Arizona, United States
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Sun City, Arizona, United States
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Tucson, Arizona, United States
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Alhambra, California, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Banning, California, United States
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Beverly Hills, California, United States
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Carlsbad, California, United States
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Concord, California, United States
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East Palo Alto, California, United States
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Fresno, California, United States
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Huntington Beach, California, United States
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Laguna Hills, California, United States
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Larkspur, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Manhattan Beach, California, United States
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Mission Hills, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Pasadena, California, United States
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Pismo Beach, California, United States
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Pomona, California, United States
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Poway, California, United States
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Rancho Mirage, California, United States
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San Pedro, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Lakewood, Colorado, United States
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Bridgeport, Connecticut, United States
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Guilford, Connecticut, United States
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Laurel, Delaware, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Bay Pines, Florida, United States
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Clearwater, Florida, United States
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Coral Springs, Florida, United States
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Eustis, Florida, United States
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Jupiter, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Miramar, Florida, United States
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Palm Harbor, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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Tampa, Florida, United States
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Wellington, Florida, United States
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Alpharetta, Georgia, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Cumming, Georgia, United States
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Gainesville, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Rome, Georgia, United States
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Smyrna, Georgia, United States
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Idaho Falls, Idaho, United States
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Pocatello, Idaho, United States
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Aurora, Illinois, United States
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Hines, Illinois, United States
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Melrose Park, Illinois, United States
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New Lenox, Illinois, United States
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North Chicago, Illinois, United States
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Peoria, Illinois, United States
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Rock Island, Illinois, United States
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Anderson, Indiana, United States
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Bloomington, Indiana, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, United States
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La Porte, Indiana, United States
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Munster, Indiana, United States
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South Bend, Indiana, United States
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Davenport, Iowa, United States
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Waterloo, Iowa, United States
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Overland Park, Kansas, United States
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Elizabethtown, Kentucky, United States
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Louisville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Alexandria, Louisiana, United States
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Bossier City, Louisiana, United States
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Natchitoches, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Rockport, Maine, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Randallstown, Maryland, United States
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Salisbury, Maryland, United States
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Fall River, Massachusetts, United States
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Alpena, Michigan, United States
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Bay City, Michigan, United States
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Flint, Michigan, United States
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Grand Blanc, Michigan, United States
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Lansing, Michigan, United States
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Lapeer, Michigan, United States
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Mount Clemens, Michigan, United States
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Rochester Hills, Michigan, United States
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Saint Joseph, Michigan, United States
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Traverse City, Michigan, United States
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Troy, Michigan, United States
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Ypsilanti, Michigan, United States
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Minneapolis, Minnesota, United States
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Bridgeton, Missouri, United States
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Kansas City, Missouri, United States
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Fremont, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Nashua, New Hampshire, United States
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Bridgewater, New Jersey, United States
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East Brunswick, New Jersey, United States
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Flemington, New Jersey, United States
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Linden, New Jersey, United States
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Manalapan, New Jersey, United States
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Moorestown, New Jersey, United States
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Mountain Lakes, New Jersey, United States
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Somerset, New Jersey, United States
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Toms River, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Wayne, New Jersey, United States
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Albany, New York, United States
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Flushing, New York, United States
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Huntington, New York, United States
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Jackson Heights, New York, United States
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Jamaica, New York, United States
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Jamestown, New York, United States
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Lake Success, New York, United States
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Mineola, New York, United States
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Mount Kisco, New York, United States
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New York, New York, United States
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North Massapequa, New York, United States
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Utica, New York, United States
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Burlington, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Greensboro, North Carolina, United States
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Pinehurst, North Carolina, United States
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Sanford, North Carolina, United States
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Spartanburg, North Carolina, United States
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Canton, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Mansfield, Ohio, United States
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Miamisburg, Ohio, United States
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Toledo, Ohio, United States
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Worthington, Ohio, United States
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Youngstown, Ohio, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Abington, Pennsylvania, United States
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Chambersburg, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Ephrata, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Providence, Rhode Island, United States
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Warwick, Rhode Island, United States
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Woonsocket, Rhode Island, United States
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Charleston, South Carolina, United States
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Easley, South Carolina, United States
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Lancaster, South Carolina, United States
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Bristol, Tennessee, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Oak Ridge, Tennessee, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Fort Sam Houston, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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McKinney, Texas, United States
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Odessa, Texas, United States
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Palestine, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Tyler, Texas, United States
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Annandale, Virginia, United States
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Lynchburg, Virginia, United States
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Mechanicsville, Virginia, United States
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Midlothian, Virginia, United States
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Newport News, Virginia, United States
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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Vancouver, Washington, United States
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Walla Walla, Washington, United States
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Charleston, West Virginia, United States
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Waukesha, Wisconsin, United States
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Wausau, Wisconsin, United States
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Río Grande, Puerto Rico
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Charlotte Amalie, Virgin Islands
Related Publications (10)
Fox KAA, Virdone S, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Oto A, Misselwitz F, Piccini JP, Dalgaard F, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.
PMID: 33892489DERIVEDJackson LR 2nd, Kim S, Blanco R, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Go AS, Kowey PR, Mahaffey KW, Hylek EM, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II. Discontinuation rates of warfarin versus direct acting oral anticoagulants in US clinical practice: Results from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). Am Heart J. 2020 Aug;226:85-93. doi: 10.1016/j.ahj.2020.04.016. Epub 2020 Apr 28.
PMID: 32526533DERIVEDJackson LR 2nd, Kim S, Fonarow GC, Freeman JV, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Singer D, Thomas L, Blanco R, Peterson ED, Piccini JP Sr; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation Patients and Investigators. Stroke Risk and Treatment in Patients with Atrial Fibrillation and Low CHA2DS2-VASc Scores: Findings From the ORBIT-AF I and II Registries. J Am Heart Assoc. 2018 Aug 21;7(16):e008764. doi: 10.1161/JAHA.118.008764.
PMID: 30369317DERIVEDInohara T, Kim S, Pieper K, Blanco RG, Allen LA, Fonarow GC, Gersh BJ, Ezekowitz MD, Kowey PR, Reiffel JA, Naccarelli GV, Chan PS, Mahaffey KW, Singer DE, Freeman JV, Steinberg BA, Peterson ED, Piccini JP; ORBIT AF Patients and Investigators. B-type natriuretic peptide, disease progression and clinical outcomes in atrial fibrillation. Heart. 2019 Mar;105(5):370-377. doi: 10.1136/heartjnl-2018-313642. Epub 2018 Sep 18.
PMID: 30228248DERIVEDSteinberg BA, Shrader P, Pieper K, Thomas L, Allen LA, Ansell J, Chan PS, Ezekowitz MD, Fonarow GC, Freeman JV, Gersh BJ, Kowey PR, Mahaffey KW, Naccarelli GV, Reiffel JA, Singer DE, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) II Investigators. Frequency and Outcomes of Reduced Dose Non-Vitamin K Antagonist Anticoagulants: Results From ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II). J Am Heart Assoc. 2018 Feb 16;7(4):e007633. doi: 10.1161/JAHA.117.007633.
PMID: 29453305DERIVEDKaufman BG, Kim S, Pieper K, Allen LA, Gersh BJ, Naccarelli GV, Ezekowitz MD, Fonarow GC, Mahaffey KW, Singer DE, Chan PS, Freeman JV, Ansell J, Kowey PR, Rieffel JA, Piccini J, Peterson E, O'Brien EC. Disease understanding in patients newly diagnosed with atrial fibrillation. Heart. 2018 Mar;104(6):494-501. doi: 10.1136/heartjnl-2017-311800. Epub 2017 Aug 8.
PMID: 28790169DERIVEDSteinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Hylek E, Kowey PR, Mahaffey KW, O'Brien EC, Singer DE, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Factors associated with non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). Am Heart J. 2017 Jul;189:40-47. doi: 10.1016/j.ahj.2017.03.024. Epub 2017 Apr 4.
PMID: 28625380DERIVEDSteinberg BA, Simon DN, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Kowey PR, Mahaffey KW, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Management of Major Bleeding in Patients With Atrial Fibrillation Treated With Non-Vitamin K Antagonist Oral Anticoagulants Compared With Warfarin in Clinical Practice (from Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF II]). Am J Cardiol. 2017 May 15;119(10):1590-1595. doi: 10.1016/j.amjcard.2017.02.015. Epub 2017 Mar 28.
PMID: 28363354DERIVEDSteinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel J, Singer DE, Peterson ED, Piccini JP; ORBIT-AF Investigators and Patients. Off-Label Dosing of Non-Vitamin K Antagonist Oral Anticoagulants and Adverse Outcomes: The ORBIT-AF II Registry. J Am Coll Cardiol. 2016 Dec 20;68(24):2597-2604. doi: 10.1016/j.jacc.2016.09.966.
PMID: 27978942DERIVEDSteinberg BA, Blanco RG, Ollis D, Kim S, Holmes DN, Kowey PR, Fonarow GC, Ansell J, Gersh B, Go AS, Hylek E, Mahaffey KW, Thomas L, Chang P, Peterson ED, Piccini JP; ORBIT-AF Steering Committee Investigators. Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II: rationale and design of the ORBIT-AF II registry. Am Heart J. 2014 Aug;168(2):160-7. doi: 10.1016/j.ahj.2014.04.005. Epub 2014 Apr 18.
PMID: 25066554DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 5, 2012
Study Start
February 20, 2013
Primary Completion
July 12, 2017
Study Completion
July 12, 2017
Last Updated
February 3, 2025
Record last verified: 2025-01