Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01165710
First received: July 16, 2010
Last updated: March 8, 2016
Last verified: March 2016
History of Changes

July 16, 2010
March 8, 2016
June 2010
November 2014   (final data collection date for primary outcome 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01165710 on ClinicalTrials.gov Archive Site
The number of major adverse cardiac events. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The number of major adverse cardiac events. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
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.
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)
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Enrolling physicians will include cardiologists, internists, and electrophysiologists from both academic and private practice who preferably have experience in registry participation.
Atrial Fibrillation
Other: Patients with Atrial Fibrillation (AF)
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
001
Patients with Atrial Fibrillation (AF) Treatment patterns of AF according to patient demographics clinical factors risk stratification and geographic regions.
Intervention: Other: Patients with Atrial Fibrillation (AF)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10179
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01165710
CR016327, RIVAROXAFL4001
No
Not Provided
Not Provided
Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
Duke Clinical Research Institute
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP