Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (Orbit-AF II)|
- Number of major bleeding events [ Time Frame: 2 years ] [ Designated as safety issue: No ]Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
- Number of major adverse cardiac events [ Time Frame: 2 years ] [ Designated as safety issue: No ]Major cardiac events are defined as stroke or non-central nervous system (non-CNS) systemic embolism, myocardial infarction, and cardiovascular death.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Patients with Atrial Fibrillation (AF)
(1) patients with new onset/first detected Atrial Fibrillation (AF) diagnosed within the preceding 6 months; or (2) patients with AF who had initiation or transition to a FXa (Factor Xa) inhibitor or a direct thrombin inhibitor within the preceding 3 months.
Other: Patients with Atrial Fibrillation
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
The registry will be used to evaluate, describe, and document the safety of target-specific anticoagulant agents (and other antithrombotic agents) in patients with Atrial Fibrillation (AF), the clinical outcomes associated with their use, the treatment patterns and clinical course of patients with AF, including those who undergo cardiac procedures of interest (ablation, cardioversion, catheterization and surgery, for examples), and characteristics of patients with new onset/first-detected AF. Additionally, the registry will be used to summarize patterns of switching or discontinuation of antithrombotic agents in the United States. The registry will be a nationwide collaboration of health care providers (eg, cardiologists, internists, primary care physicians, electrophysiologists, quality improvement personnel, office/practice managers, research coordinators, and pharmacists). Target enrollment will be approximately 15,000 patients. It is anticipated that enrollment will complete in 2 years. 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 up to 2 years. Patient follow-up by their AF care provider will continue as scheduled according to local clinical practice. Data collection will occur at 6-month intervals for approximately 2 years from the time of enrollment of the patient (baseline, 6, 12, 18, and 24 months). Data capture will include demographics, medical history, cardiovascular history, vital signs, echocardiographic and laboratory data, AF status and type (paroxysmal, persistent, long-standing persistent/permanent), pharmacotherapy, contraindications to oral anticoagulant therapy, and provider specialty. Clinical outcomes and safety data capture will include major adverse cardiac events (MACEs).
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
|United States, Alabama|
|Mobile, Alabama, United States|
|United States, California|
|Los Alamitos, California, United States|
|United States, Florida|
|Coral Springs, Florida, United States|
|United States, Illinois|
|Aurora, Illinois, United States|
|Rock Island, Illinois, United States|
|United States, Indiana|
|South Bend, Indiana, United States|
|United States, Kansas|
|Overland Park, Kansas, United States|
|United States, Michigan|
|Lansing, Michigan, United States|
|United States, Nevada|
|Las Vegas, Nevada, United States|
|United States, New Jersey|
|Toms River, New Jersey, United States|
|United States, North Carolina|
|Sanford, North Carolina, United States|
|United States, Ohio|
|Mansfield, Ohio, United States|
|Miamisburg, Ohio, United States|
|United States, Texas|
|Odessa, Texas, United States|
|Tomball, Texas, United States|
|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|