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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Janssen Scientific Affairs, LLC
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01701817
First received: October 3, 2012
Last updated: September 17, 2014
Last verified: September 2014

October 3, 2012
September 17, 2014
February 2013
September 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01701817 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
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.

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).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
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.
Intervention: Other: Patients with Atrial Fibrillation
Steinberg BA, Blanco RG, Ollis D, Kim S, Holmes DN, Kowey PR, Fonarow GC, Ansell J, Gersh B, Go AS, Hylek E, Mahaffey KW, Thomas L, Chang P, Peterson ED, Piccini JP; ORBIT-AF Steering Committee Investigators. Outcomes registry for better informed treatment of atrial fibrillation II: rationale and design of the ORBIT-AF II registry. Am Heart J. 2014 Aug;168(2):160-7. doi: 10.1016/j.ahj.2014.04.005. Epub 2014 Apr 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15000
March 2017
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria: - Adult patients with incident (initial diagnosis) AF (Atrial Fibrillation) with electrocardiographic documentation or patients with prevalent (existing diagnosis) AF who had initiation or transition to a FXa (Factor Xa) inhibitor or a direct thrombin inhibitor within the preceding 3 months - anticipated ability to adhere to local regularly scheduled follow-up visits

-

Exclusion Criteria:

  • Atrial flutter only - 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 - Was enrolled in the ORBIT-I Registry
Both
21 Years and older
No
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,   Puerto Rico
 
NCT01701817
CR100871, RIVAROXAFL4002
No
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
September 2014

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