Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)

NCT ID: NCT01165710

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10179 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-12-31

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)

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

001

Patients with Atrial Fibrillation (AF) Treatment patterns of AF according to patient demographics clinical factors risk stratification and geographic regions.

Patients with Atrial Fibrillation (AF)

Intervention Type: OTHER

Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.

Interventions

Patients with Atrial Fibrillation (AF)

Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

Birmingham, Alabama, United States

Dothan, Alabama, United States

Huntsville, Alabama, United States

Mobile, Alabama, United States

Montgomery, Alabama, United States

Pell City, Alabama, United States

Tuscaloosa, Alabama, United States

Cottonwood, Arizona, United States

Tucson, Arizona, United States

Fort Smith, Arkansas, United States

Carlsbad, California, United States

Carmichael, California, United States

Corona, California, United States

Laguna Hills, California, United States

Long Beach, California, United States

Los Alamitos, California, United States

Los Angeles, California, United States

Montebello, California, United States

Northridge, California, United States

Orange, California, United States

Oxnard, California, United States

Palo Alto, California, United States

Pismo Beach, California, United States

Pomona, California, United States

San Diego, California, United States

San Ramon, California, United States

Santa Rosa, California, United States

Tarzana, California, United States

Torrance, California, United States

Tustin, California, United States

Ventura, California, United States

Aurora, Colorado, United States

Colorado Springs, Colorado, United States

Golden, Colorado, United States

Newark, Delaware, United States

Seaford, Delaware, United States

Boynton Beach, Florida, United States

Coral Springs, Florida, United States

Deerfield Beach, Florida, United States

Fort Myers, Florida, United States

Fort Walton Beach, Florida, United States

Hollywood, Florida, United States

Jupiter, Florida, United States

Lakeland, Florida, United States

Oakland Park, Florida, United States

Orange Park, Florida, United States

Ormond Beach, Florida, United States

Port Charlotte, Florida, United States

St. Petersburg, Florida, United States

Tallahassee, Florida, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Marietta, Georgia, United States

Riverdale, Georgia, United States

Idaho Falls, Idaho, United States

Nampa, Idaho, United States

Aurora, Illinois, United States

Evergreen Park, Illinois, United States

Melrose Park, Illinois, United States

Peoria, Illinois, United States

Rock Island, Illinois, United States

Rockford, Illinois, United States

Urbana, Illinois, United States

Winfield, Illinois, United States

Bloomington, Indiana, United States

Evansville, Indiana, United States

Hammond, Indiana, United States

Indianapolis, Indiana, United States

La Porte, Indiana, United States

South Bend, Indiana, United States

Waterloo, Iowa, United States

Overland Park, Kansas, United States

Crestview Hills, Kentucky, United States

Lexington, Kentucky, United States

Owensboro, Kentucky, United States

Alexandria, Louisiana, United States

Rockport, Maine, United States

Beltsville, Maryland, United States

Salisbury, Maryland, United States

Biddeford, Massachusetts, United States

Bay City, Michigan, United States

Bridgman, Michigan, United States

Commerce, Michigan, United States

Grand Blanc, Michigan, United States

Lansing, Michigan, United States

Livonia, Michigan, United States

Mount Clemens, Michigan, United States

Stevensville, Michigan, United States

Traverse City, Michigan, United States

Troy, Michigan, United States

Minneapolis, Minnesota, United States

Anaconda, Montana, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Bridgewater, New Jersey, United States

Elmer, New Jersey, United States

Haddon Heights, New Jersey, United States

Linden, New Jersey, United States

Nampa, New Jersey, United States

Ridgewood, New Jersey, United States

Sewell, New Jersey, United States

Toms River, New Jersey, United States

Flushing, New York, United States

Huntington, New York, United States

Jamaica, New York, United States

New York, New York, United States

Northport, New York, United States

Calabash, North Carolina, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Greenwood, North Carolina, United States

Jacksonville, North Carolina, United States

Pinehurst, North Carolina, United States

Raleigh, North Carolina, United States

Sanford, North Carolina, United States

Tabor City, North Carolina, United States

Winston-Salem, North Carolina, United States

Fargo, North Dakota, United States

Minot, North Dakota, United States

Mansfield, Ohio, United States

Miamisburg, Ohio, United States

Piqua, Ohio, United States

Toledo, Ohio, United States

Worthington, Ohio, United States

Youngstown, Ohio, United States

Abington, Pennsylvania, United States

Beaver, Pennsylvania, United States

Danville, Pennsylvania, United States

Doylestown, Pennsylvania, United States

Erie, Pennsylvania, United States

Lansdale, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Scranton, Pennsylvania, United States

Spring House, Pennsylvania, United States

West Reading, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Yardley, Pennsylvania, United States

Pawtucket, Rhode Island, United States

Anderson, South Carolina, United States

Easley, South Carolina, United States

Spartanburg, South Carolina, United States

Harriman, Tennessee, United States

Kingsport, Tennessee, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Beaumont, Texas, United States

Corpus Christi, Texas, United States

Flower Mound, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

McAllen, Texas, United States

Odessa, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Tomball, Texas, United States

Salt Lake City, Utah, United States

Fredericksburg, Virginia, United States

Lynchburg, Virginia, United States

Midlothian, Virginia, United States

Roanoke, Virginia, United States

Winchester, Virginia, United States

Burien, Washington, United States

Port Orchard, Washington, United States

Spokane, Washington, United States

Tacoma, Washington, United States

Vancouver, Washington, United States

La Crosse, Wisconsin, United States

Madison, Wisconsin, United States

Hato Rey, , Puerto Rico

Río Grande, , Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

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Other Identifiers

RIVAROXAFL4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR016327

Identifier Type: -

Identifier Source: org_study_id