Ignite Creation Date:
2024-05-05 @ 10:42 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01165710
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2010-07-16
Brief Title:
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation ORBIT-AF
Sponsor:
Janssen Scientific Affairs LLC
Organization:
Janssen Scientific Affairs LLC
Study Overview
Official Title:
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation ORBIT-AF
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10000 prospective cohort of patients will be enrolled The registry will be a nation-wide collaboration of Health Care Providers eg cardiologists internists primary care physicians electrophysiologists quality improvement personnel officepractice 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 1500 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 eg 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 sponsors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RIVAROXAFL4001 | OTHER | Janssen Scientific Affairs LLC | None |