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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701817
First Posted: October 5, 2012
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Duke Clinical Research Institute
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
  Purpose
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.

Condition Intervention
Atrial Fibrillation Other: Patients with Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (Orbit-AF II)

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Number of major bleeding events [ Time Frame: 2 years ]
    Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.


Secondary Outcome Measures:
  • 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.


Enrollment: 13785
Actual Study Start Date: February 20, 2013
Study Completion Date: July 12, 2017
Primary Completion Date: July 12, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701817


  Hide Study Locations
Locations
United States, Alabama
Cullman, Alabama, United States
Dothan, Alabama, United States
Fairhope, Alabama, United States
Mobile, Alabama, United States
Tuscaloosa, Alabama, United States
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
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
United States, Colorado
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
United States, Connecticut
Bridgeport, Connecticut, United States
Guilford, Connecticut, United States
United States, Delaware
Laurel, Delaware, United States
Newark, Delaware, United States
United States, District of Columbia
Washington, District of Columbia, United States
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
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
United States, Idaho
Idaho Falls, Idaho, United States
Pocatello, Idaho, United States
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
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
United States, Iowa
Davenport, Iowa, United States
Waterloo, Iowa, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Kentucky
Elizabethtown, Kentucky, United States
Louisville, Kentucky, United States
Mount Sterling, Kentucky, United States
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
United States, Maine
Rockport, Maine, United States
United States, Maryland
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Randallstown, Maryland, United States
Salisbury, Maryland, United States
United States, Massachusetts
Fall River, Massachusetts, United States
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
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Bridgeton, Missouri, United States
Kansas City, Missouri, United States
United States, Nebraska
Fremont, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
Reno, Nevada, United States
United States, New Hampshire
Nashua, New Hampshire, United States
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
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
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
Raleigh, North Carolina, United States
Sanford, North Carolina, United States
Spartanburg, North Carolina, United States
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
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
Portland, Oregon, United States
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
United States, Rhode Island
Providence, Rhode Island, United States
Warwick, Rhode Island, United States
Woonsocket, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States
Easley, South Carolina, United States
Lancaster, South Carolina, United States
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
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
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
United States, Washington
Seattle, Washington, United States
Tacoma, Washington, United States
Vancouver, Washington, United States
Walla Walla, Washington, United States
United States, West Virginia
Charleston, West Virginia, United States
United States, Wisconsin
La Crosse, Wisconsin, United States
Milwaukee, Wisconsin, United States
Waukesha, Wisconsin, United States
Wausau, Wisconsin, United States
Puerto Rico
Rio Grande, Puerto Rico
Virgin Islands (U.S.)
Saint Thomas, Virgin Islands (U.S.)
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Duke Clinical Research Institute
Bayer
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01701817     History of Changes
Other Study ID Numbers: CR100871
RIVAROXAFL4002 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: October 3, 2012
First Posted: October 5, 2012
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by Janssen Scientific Affairs, LLC:
Atrial Fibrillation
Irregular heart beat

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes