Clinical trial NCT01701817: Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
Official title: Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (Orbit-AF II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Irregular heart beat
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
name: Bayer
First posted: 2012-10-05
Enrollment: 13769
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolling physicians will include cardiologists, internists, and electrophysiologists from both academic and private practice who preferably have experience in registry participation.

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.

Detailed description: The registry will be used to evaluate, describe, and document the safety of target-specific anticoagulant agents (and other antithrombotic agents) in patients with Atrial Fibrillation (AF), the clinical outcomes associated with their use, the treatment patterns and clinical course of patients with AF, including those who undergo cardiac procedures of interest (ablation, cardioversion, catheterization and surgery, for examples), and characteristics of patients with new onset/first-detected AF. Additionally, the registry will be used to summarize patterns of switching or discontinuation of antithrombotic agents in the United States. The registry will be a nationwide collaboration of health care providers (eg, cardiologists, internists, primary care physicians, electrophysiologists, quality improvement personnel, office/practice managers, research coordinators, and pharmacists). Target enrollment will be approximately 15,000 patients. It is anticipated that enrollment will complete in approximately 3.5 years. Consecutive patients who meet the eligibility criteria will be approached and educated about the registry. Patients who express interest will provide informed consent. Patients enrolled in the registry will be followed for up to 2 years. New patients enrolled in the registry will be followed for up to 1 year. Patient follow-up by their AF care provider will continue as scheduled according to local clinical practice. Data collection will occur at 6 month intervals for approximately 1 year from the time of enrollment of the patient (baseline, 6, and 12 months). Data capture will include demographics, medical history, cardiovascular history, vital signs, echocardiographic and laboratory data, AF status and type (paroxysmal, persistent, long-standing persistent/permanent), pharmacotherapy, contraindications to oral anticoagulant therapy, and provider specialty. Clinical outcomes and safety data capture will include major adverse cardiac events (MACEs).

Eligibility criteria: Inclusion Criteria: - Adult patients with incident (initial diagnosis) AF (Atrial Fibrillation) with electrocardiographic documentation or patients with prevalent (existing diagnosis) AF who had initiation or transition to a FXa (Factor Xa) inhibitor or a direct thrombin inhibitor within the preceding 3 months - anticipated ability to adhere to local regularly scheduled follow-up visits

-

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of major bleeding events
timeFrame: 2 years
Secondary outcomes:
measure: Number of major adverse cardiac events
timeFrame: 2 years
Other outcomes:
Locations:
city: Cullman
country: United States
state: Alabama
city: Dothan
country: United States
state: Alabama
city: Fairhope
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Avondale
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Goodyear
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Alhambra
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: Banning
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Carlsbad
country: United States
state: California
city: Concord
country: United States
state: California
city: East Palo Alto
country: United States
state: California
city: Fresno
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Larkspur
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Los Angeles
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state: California
city: Manhattan Beach
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city: Newport Beach
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city: Northridge
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country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Pomona
country: United States
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country: United States
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city: Rancho Mirage
country: United States
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city: Torrance
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city: Colorado Springs
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city: Laurel
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city: Newark
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city: Washington
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state: District of Columbia
city: Bay Pines
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city: Clearwater
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state: Georgia
city: Athens
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state: Georgia
city: Atlanta
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city: Cumming
country: United States
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country: United States
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city: Rome
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city: Pocatello
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city: Hines
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city: North Chicago
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city: Bloomington
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city: Indianapolis
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city: Annapolis
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city: Baltimore
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city: Randallstown
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city: Fall River
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city: Alpena
country: United States
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city: Bay City
country: United States
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city: Flint
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city: Grand Blanc
country: United States
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city: Lansing
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city: Lapeer
country: United States
state: Michigan
city: Mount Clemens
country: United States
state: Michigan
city: Rochester Hills
country: United States
state: Michigan
city: Saint Joseph
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
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city: Bridgeton
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city: Kansas City
country: United States
state: Missouri
city: Fremont
country: United States
state: Nebraska
city: Las Vegas
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state: New Hampshire
city: Bridgewater
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city: East Brunswick
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city: Flemington
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city: Linden
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city: Moorestown
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city: Jamaica
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city: Lake Success
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city: Mineola
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city: Mount Kisco
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city: North Massapequa
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state: North Carolina
city: Chapel Hill
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state: North Carolina
city: Durham
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city: Elizabeth City
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city: Greensboro
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city: Pinehurst
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city: Canton
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state: Ohio
city: Cleveland
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city: Columbus
country: United States
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city: Mansfield
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city: Miamisburg
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city: Worthington
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city: Youngstown
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city: Tulsa
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state: Oklahoma
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state: Oregon
city: Portland
country: United States
state: Oregon
city: Abington
country: United States
state: Pennsylvania
city: Chambersburg
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Ephrata
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Yardley
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Warwick
country: United States
state: Rhode Island
city: Woonsocket
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Easley
country: United States
state: South Carolina
city: Lancaster
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Oak Ridge
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Sam Houston
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Palestine
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Round Rock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Lynchburg
country: United States
state: Virginia
city: Mechanicsville
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Newport News
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Walla Walla
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
city: La Crosse
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Waukesha
country: United States
state: Wisconsin
city: Wausau
country: United States
state: Wisconsin
city: Rio Grande
country: Puerto Rico
city: Saint Thomas
country: Virgin Islands (U.S.)
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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citation: Steinberg 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.