Clinical trial NCT01165710: Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
Official title: Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Irregular heart beat
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
name: Bayer
First posted: 2010-07-20
Enrollment: 10179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 ORBIT-AF registry will be a multicenter, prospective outpatient disease registry to identify "real world" treatment patterns of atrial fibrillation. The registry will describe this patient population with regards to demographics, clinical factors, risk stratification, and geographic regions. In particular, attention will be focused on the utilization, effectiveness, and safety of antithrombotic therapies in the prevention of stroke. The registry is designed to identify reasons and risk factors for non-receipt of anticoagulation (AC) therapy, as well as reasons why AF patients who are prescribed AC therapy do not take them.

Detailed description: The ORBIT-AF registry is a multicenter prospective outpatient disease registry of patients with incident (initial diagnosis) or prevalent (existing diagnosis) atrial fibrillation (AF) that will analyze treatment patterns and outcomes in patients with AF in the US. Approximately 10,000 prospective cohort of patients will be enrolled. The registry will be a nation-wide collaboration of Health Care Providers (e.g., cardiologists, internists, primary care physicians, electrophysiologists, quality improvement personnel, office/practice managers, research coordinators, and pharmacists). This collaborative effort will be focused on the optimization of outpatient management of patients with AF. 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 approximately 3 years. Patient follow-up by their AF care provider will continue as scheduled according to local clinical practice. Patient Reported outcome (PRO) questionnaires will be administered to a sub-sample of approximately 1,500 patients. For patients who consent to answer PRO questionnaires, these questionnaires will be administered by the site to the patient at the baseline visit \[except the baseline Anticoagulation-Related Treatment Satisfaction (ACTS)\] and during their regularly scheduled follow-up visits. The baseline ACTS for incident patients will be completed and returned back to the site at least 4 weeks after starting antithrombotic therapies. The ACTS questionnaire will only be administered to patients who are taking antithrombotic therapies within the 4 weeks before a visit or newly prescribed antithrombotic therapies. Data collection will occur at 6-month intervals for a minimum of 3 years (baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months). The data collection windows will be wide (3 months in either direction) in order to maximize data collection during the patients regularly scheduled follow-up with their AF care provider. Collection of Patient Reported Outcome (PRO) Questionnaires will not continue beyond the 24-month data collection interval. Atrial Fibrillation Data capture will include demographics, cardiovascular risk factors, diagnosis, type of AF (paroxysmal, persistent, permanent AF), treatment strategy (rate vs. rhythm), ablation history, cardioversions, antithrombotic therapy decisions and monitoring (INRs), concomitant medications and doses, insurance and provider information, AF quality-of-life, anticoagulation treatment satisfaction, caregiver assistance, pet ownership, comorbidities, compliance, and outcomes. Pre-defined outcomes of interest will include stroke or non-CNS (non-systemic) embolism, major adverse cardiac events, all-cause mortality, cause-specific death (sudden, non-sudden, heart failure-related), major bleeding, AF-related quality of life, anticoagulation-related treatment satisfaction, all-cause hospitalization and specific anticoagulation outcomes (e.g. time in therapeutic range and primary discontinuation of oral anticoagulation). The data generated by this registry will be used to identify real world practice, especially as it compares and relates to guidelines set forth by the American College of Cardiology, American Heart Association and European Society of Cardiology for the management of patients with AF. Observational Study - No investigational drug administered. For any patients receiving the sponsor's drug, Xarelto (rivaroxaban), under the direction of a physician, all serious adverse events and all non-serious related events will be reported to the sponsor (Janssen Scientific Affairs, LLC)

Eligibility criteria: Inclusion Criteria:

* Adult patients with incident (initial diagnosis) or prevalent (existing diagnosis) AF with electrocardiographic documentation
* anticipated ability to adhere to local regularly scheduled follow-up visits

Exclusion Criteria:

* 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

Primary outcomes:
measure: The primary outcome is stroke or non-CNS (systemic) embolism. Key primary objective is: characterize & describe the AF patient population as a whole, with emphasis on demographics, comorbidities, and risk profiles.
timeFrame: 3 years
Secondary outcomes:
measure: The number of major adverse cardiac events.
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Dothan
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Pell City
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Cottonwood
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fort Smith
country: United States
state: Arkansas
city: Carlsbad
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Corona
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Montebello
country: United States
state: California
city: Northridge
country: United States
state: California
city: Orange
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Pomona
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Ramon
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Tustin
country: United States
state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Golden
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Seaford
country: United States
state: Delaware
city: Boynton Beach
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Fort Walton Beach
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jupiter
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city: Lakeland
country: United States
state: Florida
city: Oakland Park
country: United States
state: Florida
city: Orange Park
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Riverdale
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Nampa
country: United States
state: Idaho
city: Aurora
country: United States
state: Illinois
city: Evergreen Park
country: United States
state: Illinois
city: Melrose Park
country: United States
state: Illinois
city: Peoria
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state: Illinois
city: Rock Island
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Urbana
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state: Illinois
city: Winfield
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state: Illinois
city: Bloomington
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state: Indiana
city: Evansville
country: United States
state: Indiana
city: Hammond
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: La Porte
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Waterloo
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Crestview Hills
country: United States
state: Kentucky
city: Lexington
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state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Alexandria
country: United States
state: Louisiana
city: Rockport
country: United States
state: Maine
city: Beltsville
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Biddeford
country: United States
state: Massachusetts
city: Bay City
country: United States
state: Michigan
city: Bridgman
country: United States
state: Michigan
city: Commerce Township
country: United States
state: Michigan
city: Grand Blanc
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Livonia
country: United States
state: Michigan
city: Mount Clemens
country: United States
state: Michigan
city: Stevensville
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Anaconda
country: United States
state: Montana
city: Omaha
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state: Nebraska
city: Las Vegas
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state: Nevada
city: Bridgewater
country: United States
state: New Jersey
city: Elmer
country: United States
state: New Jersey
city: Haddon Heights
country: United States
state: New Jersey
city: Linden
country: United States
state: New Jersey
city: Nampa
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: Sewell
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: New York
country: United States
state: New York
city: Northport
country: United States
state: New York
city: Calabash
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greenwood
country: United States
state: North Carolina
city: Jacksonville
country: United States
state: North Carolina
city: Pinehurst
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Sanford
country: United States
state: North Carolina
city: Tabor City
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Minot
country: United States
state: North Dakota
city: Mansfield
country: United States
state: Ohio
city: Miamisburg
country: United States
state: Ohio
city: Piqua
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Worthington
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Abington
country: United States
state: Pennsylvania
city: Beaver
country: United States
state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Spring House
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: Pawtucket
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Easley
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Harriman
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Flower Mound
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Mcallen
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fredericksburg
country: United States
state: Virginia
city: Lynchburg
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Burien
country: United States
state: Washington
city: Port Orchard
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: La Crosse
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
city: Hato Rey
country: Puerto Rico
city: Rio Grande
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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