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

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ClinicalTrials.gov Identifier: NCT01701817
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Duke Clinical Research Institute
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Tracking Information
First Submitted Date October 3, 2012
First Posted Date October 5, 2012
Last Update Posted Date December 15, 2017
Actual Study Start Date February 20, 2013
Actual Primary Completion Date July 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2012)
Number of major bleeding events [ Time Frame: 2 years ]
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01701817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 4, 2012)
Number of major adverse cardiac events [ Time Frame: 2 years ]
Major cardiac events are defined as stroke or non-central nervous system (non-CNS) systemic embolism, myocardial infarction, and cardiovascular death.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
Official Title Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (Orbit-AF II)
Brief Summary 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.
Detailed Description 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 approximately 3.5 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. New patients enrolled in the registry will be followed for up to 1 year. 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 1 year from the time of enrollment of the patient (baseline, 6, and 12 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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
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 Atrial Fibrillation
Intervention Other: Patients with Atrial Fibrillation
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
Study Groups/Cohorts Patients with Atrial Fibrillation (AF)
(1) patients with new onset/first detected Atrial Fibrillation (AF) diagnosed within the 6 months preceding the baseline visit; 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 14, 2017)
13785
Original Estimated Enrollment
 (submitted: October 4, 2012)
15000
Actual Study Completion Date July 12, 2017
Actual Primary Completion Date July 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Puerto Rico,   United States,   Virgin Islands (U.S.)
Removed Location Countries  
 
Administrative Information
NCT Number NCT01701817
Other Study ID Numbers CR100871
RIVAROXAFL4002 ( Other Identifier: Janssen Scientific Affairs, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Janssen Scientific Affairs, LLC
Study Sponsor Janssen Scientific Affairs, LLC
Collaborators
  • Duke Clinical Research Institute
  • Bayer
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
PRS Account Janssen Scientific Affairs, LLC
Verification Date December 2017