Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
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| ClinicalTrials.gov Identifier: NCT01165710 |
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Recruitment Status
:
Completed
First Posted
: July 20, 2010
Last Update Posted
: January 24, 2017
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Sponsor:
Janssen Scientific Affairs, LLC
Collaborators:
Duke Clinical Research Institute
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Atrial Fibrillation | Other: Patients with Atrial Fibrillation (AF) |
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)
| Study Type : | Observational |
| Actual Enrollment : | 10179 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | November 2014 |
| Actual Study Completion Date : | December 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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001
Patients with Atrial Fibrillation (AF) Treatment patterns of AF according to patient demographics clinical factors risk stratification and geographic regions.
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Other: Patients with Atrial Fibrillation (AF)
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
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Primary Outcome Measures
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- 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. [ Time Frame: 3 years ]
Secondary Outcome Measures
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- The number of major adverse cardiac events. [ Time Frame: 3 years ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165710
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Locations
| United States, Alabama | |
| 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 | |
| United States, Arizona | |
| Cottonwood, Arizona, United States | |
| Tucson, Arizona, United States | |
| United States, Arkansas | |
| Fort Smith, Arkansas, United States | |
| United States, California | |
| 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 | |
| United States, Colorado | |
| Aurora, Colorado, United States | |
| Colorado Springs, Colorado, United States | |
| Golden, Colorado, United States | |
| United States, Delaware | |
| Newark, Delaware, United States | |
| Seaford, Delaware, United States | |
| United States, Florida | |
| 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 | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Decatur, Georgia, United States | |
| Marietta, Georgia, United States | |
| Riverdale, Georgia, United States | |
| United States, Idaho | |
| Idaho Falls, Idaho, United States | |
| Nampa, Idaho, United States | |
| United States, Illinois | |
| 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 | |
| United States, Indiana | |
| 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 | |
| United States, Iowa | |
| Waterloo, Iowa, United States | |
| United States, Kansas | |
| Overland Park, Kansas, United States | |
| United States, Kentucky | |
| Crestview Hills, Kentucky, United States | |
| Lexington, Kentucky, United States | |
| Owensboro, Kentucky, United States | |
| United States, Louisiana | |
| Alexandria, Louisiana, United States | |
| United States, Maine | |
| Rockport, Maine, United States | |
| United States, Maryland | |
| Beltsville, Maryland, United States | |
| Salisbury, Maryland, United States | |
| United States, Massachusetts | |
| Biddeford, Massachusetts, United States | |
| United States, Michigan | |
| Bay City, Michigan, United States | |
| Bridgman, Michigan, United States | |
| Commerce Township, 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 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States | |
| United States, Montana | |
| Anaconda, Montana, United States | |
| United States, Nebraska | |
| Omaha, Nebraska, United States | |
| United States, Nevada | |
| Las Vegas, Nevada, United States | |
| United States, New Jersey | |
| 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 | |
| United States, New York | |
| 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 | |
| United States, North Carolina | |
| 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 | |
| United States, North Dakota | |
| Fargo, North Dakota, United States | |
| Minot, North Dakota, United States | |
| United States, Ohio | |
| Mansfield, Ohio, United States | |
| Miamisburg, Ohio, United States | |
| Piqua, Ohio, United States | |
| Toledo, Ohio, United States | |
| Worthington, Ohio, United States | |
| Youngstown, Ohio, United States | |
| United States, Pennsylvania | |
| 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 | |
| United States, Rhode Island | |
| Pawtucket, Rhode Island, United States | |
| United States, South Carolina | |
| Anderson, South Carolina, United States | |
| Easley, South Carolina, United States | |
| Spartanburg, South Carolina, United States | |
| United States, Tennessee | |
| Harriman, Tennessee, United States | |
| Kingsport, Tennessee, United States | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| 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 | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Fredericksburg, Virginia, United States | |
| Lynchburg, Virginia, United States | |
| Midlothian, Virginia, United States | |
| Roanoke, Virginia, United States | |
| Winchester, Virginia, United States | |
| United States, Washington | |
| Burien, Washington, United States | |
| Port Orchard, Washington, United States | |
| Spokane, Washington, United States | |
| Tacoma, Washington, United States | |
| Vancouver, Washington, United States | |
| United States, Wisconsin | |
| La Crosse, Wisconsin, United States | |
| Madison, Wisconsin, United States | |
| Puerto Rico | |
| Hato Rey, Puerto Rico | |
| Rio Grande, Puerto Rico | |
| San Juan, Puerto Rico | |
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Duke Clinical Research Institute
Bayer
Investigators
| Study Director: | Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Janssen Scientific Affairs, LLC |
| ClinicalTrials.gov Identifier: | NCT01165710 History of Changes |
| Other Study ID Numbers: |
CR016327 RIVAROXAFL4001 ( Other Identifier: Janssen Scientific Affairs, LLC ) |
| First Posted: | July 20, 2010 Key Record Dates |
| Last Update Posted: | January 24, 2017 |
| Last Verified: | January 2017 |
Keywords provided by Janssen Scientific Affairs, LLC:
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Irregular heart beat |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |