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Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
This study has been completed.
Sponsor:
Janssen Scientific Affairs, LLC
Collaborators:
Duke Clinical Research Institute
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01165710
First received: July 16, 2010
Last updated: January 23, 2017
Last verified: January 2017
| Tracking Information | ||||
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| First Received Date ICMJE | July 16, 2010 | |||
| Last Updated Date | January 23, 2017 | |||
| Start Date ICMJE | June 2010 | |||
| Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
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 ] | |||
| Original Primary Outcome Measures ICMJE |
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 ] | |||
| Change History | Complete list of historical versions of study NCT01165710 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
The number of major adverse cardiac events. [ Time Frame: 3 years ] | |||
| Original Secondary Outcome Measures ICMJE |
The number of major adverse cardiac events. [ Time Frame: 2 years ] | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) | |||
| Official Title ICMJE | Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) | |||
| 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) | |||
| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| 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. | |||
| Condition ICMJE | Atrial Fibrillation | |||
| Intervention ICMJE | 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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| Study Groups/Cohorts | 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) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 10179 | |||
| Completion Date | December 2014 | |||
| Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Puerto Rico, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01165710 | |||
| Other Study ID Numbers ICMJE | CR016327 RIVAROXAFL4001 ( Other Identifier: Janssen Scientific Affairs, LLC ) |
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| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Janssen Scientific Affairs, LLC | |||
| Study Sponsor ICMJE | Janssen Scientific Affairs, LLC | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Janssen Scientific Affairs, LLC | |||
| Verification Date | January 2017 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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