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

July 20, 2020 updated by: Janssen Scientific Affairs, LLC

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

13769

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Rio Grande, Puerto Rico
  • United States
    • Alabama
      • Cullman, Alabama, United States
      • Dothan, Alabama, United States
      • Fairhope, Alabama, United States
      • Mobile, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Avondale, Arizona, United States
      • Glendale, Arizona, United States
      • Goodyear, Arizona, United States
      • Scottsdale, Arizona, United States
      • Sun City, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Alhambra, California, United States
      • Anaheim, California, United States
      • Bakersfield, California, United States
      • Banning, California, United States
      • Beverly Hills, California, United States
      • Carlsbad, California, United States
      • Concord, California, United States
      • East Palo Alto, California, United States
      • Fresno, California, United States
      • Huntington Beach, California, United States
      • Laguna Hills, California, United States
      • Larkspur, California, United States
      • Long Beach, California, United States
      • Los Alamitos, California, United States
      • Los Angeles, California, United States
      • Manhattan Beach, California, United States
      • Mission Hills, California, United States
      • Newport Beach, California, United States
      • Northridge, California, United States
      • Pasadena, California, United States
      • Pismo Beach, California, United States
      • Pomona, California, United States
      • Poway, California, United States
      • Rancho Mirage, California, United States
      • San Pedro, California, United States
      • Santa Rosa, California, United States
      • Torrance, California, United States
      • Ventura, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Lakewood, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
      • Guilford, Connecticut, United States
    • Delaware
      • Laurel, Delaware, United States
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bay Pines, Florida, United States
      • Clearwater, Florida, United States
      • Coral Springs, Florida, United States
      • Eustis, Florida, United States
      • Jupiter, Florida, United States
      • Lakeland, Florida, United States
      • Miami, Florida, United States
      • Miramar, Florida, United States
      • Palm Harbor, Florida, United States
      • Pensacola, Florida, United States
      • Port Charlotte, Florida, United States
      • Tampa, Florida, United States
      • Wellington, Florida, United States
    • Georgia
      • Alpharetta, Georgia, United States
      • Athens, Georgia, United States
      • Atlanta, Georgia, United States
      • Cumming, Georgia, United States
      • Gainesville, Georgia, United States
      • Macon, Georgia, United States
      • Marietta, Georgia, United States
      • Rome, Georgia, United States
      • Smyrna, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
      • Pocatello, Idaho, United States
    • Illinois
      • Aurora, Illinois, United States
      • Hines, Illinois, United States
      • Melrose Park, Illinois, United States
      • New Lenox, Illinois, United States
      • North Chicago, Illinois, United States
      • Peoria, Illinois, United States
      • Rock Island, Illinois, United States
    • Indiana
      • Anderson, Indiana, United States
      • Bloomington, Indiana, United States
      • Hammond, Indiana, United States
      • Indianapolis, Indiana, United States
      • La Porte, Indiana, United States
      • Munster, Indiana, United States
      • South Bend, Indiana, United States
    • Iowa
      • Davenport, Iowa, United States
      • Waterloo, Iowa, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Kentucky
      • Elizabethtown, Kentucky, United States
      • Louisville, Kentucky, United States
      • Mount Sterling, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Bossier City, Louisiana, United States
      • Natchitoches, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Rockport, Maine, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Baltimore, Maryland, United States
      • Randallstown, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Fall River, Massachusetts, United States
    • Michigan
      • Alpena, Michigan, United States
      • Bay City, Michigan, United States
      • Flint, Michigan, United States
      • Grand Blanc, Michigan, United States
      • Lansing, Michigan, United States
      • Lapeer, Michigan, United States
      • Mount Clemens, Michigan, United States
      • Rochester Hills, Michigan, United States
      • Saint Joseph, Michigan, United States
      • Traverse City, Michigan, United States
      • Troy, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Bridgeton, Missouri, United States
      • Kansas City, Missouri, United States
    • Nebraska
      • Fremont, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
      • Reno, Nevada, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • East Brunswick, New Jersey, United States
      • Flemington, New Jersey, United States
      • Linden, New Jersey, United States
      • Manalapan, New Jersey, United States
      • Moorestown, New Jersey, United States
      • Mountain Lakes, New Jersey, United States
      • Somerset, New Jersey, United States
      • Toms River, New Jersey, United States
      • Voorhees, New Jersey, United States
      • Wayne, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Flushing, New York, United States
      • Huntington, New York, United States
      • Jackson Heights, New York, United States
      • Jamaica, New York, United States
      • Jamestown, New York, United States
      • Lake Success, New York, United States
      • Mineola, New York, United States
      • Mount Kisco, New York, United States
      • New York, New York, United States
      • North Massapequa, New York, United States
      • Utica, New York, United States
    • North Carolina
      • Burlington, North Carolina, United States
      • Chapel Hill, North Carolina, United States
      • Durham, North Carolina, United States
      • Elizabeth City, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Pinehurst, North Carolina, United States
      • Sanford, North Carolina, United States
      • Spartanburg, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Mansfield, Ohio, United States
      • Miamisburg, Ohio, United States
      • Toledo, Ohio, United States
      • Worthington, Ohio, United States
      • Youngstown, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Chambersburg, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Ephrata, Pennsylvania, United States
      • Langhorne, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
      • Yardley, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
      • Warwick, Rhode Island, United States
      • Woonsocket, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Easley, South Carolina, United States
      • Lancaster, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Jackson, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
      • Oak Ridge, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Fort Sam Houston, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Katy, Texas, United States
      • McKinney, Texas, United States
      • Odessa, Texas, United States
      • Palestine, Texas, United States
      • Plano, Texas, United States
      • Round Rock, Texas, United States
      • San Antonio, Texas, United States
      • Tomball, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Annandale, Virginia, United States
      • Lynchburg, Virginia, United States
      • Mechanicsville, Virginia, United States
      • Midlothian, Virginia, United States
      • Newport News, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
      • Vancouver, Washington, United States
      • Walla Walla, Washington, United States
    • West Virginia
      • Charleston, West Virginia, United States
    • Wisconsin
      • La Crosse, Wisconsin, United States
      • Milwaukee, Wisconsin, United States
      • Waukesha, Wisconsin, United States
      • Wausau, Wisconsin, United States
  • Virgin Islands (U.S.)
      • Saint Thomas, Virgin Islands (U.S.)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Patients with Atrial Fibrillation
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of major bleeding events
Time Frame: 2 years
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Scientific Affairs, LLC

Collaborators

Bayer
Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2013

Primary Completion (Actual)

July 12, 2017

Study Completion (Actual)

July 12, 2017

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100871
  • RIVAROXAFL4002 (Other Identifier: Janssen Scientific Affairs, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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