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

NCT ID: NCT01701817

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13769 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-20
• Study Completion Date: 2017-07-12

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).

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Patients with Atrial Fibrillation

Intervention Type: OTHER

Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.

Interventions

Patients with Atrial Fibrillation

Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

Cullman, Alabama, United States

Dothan, Alabama, United States

Fairhope, Alabama, United States

Mobile, Alabama, United States

Tuscaloosa, Alabama, United States

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

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

Aurora, Colorado, United States

Colorado Springs, Colorado, United States

Lakewood, Colorado, United States

Bridgeport, Connecticut, United States

Guilford, Connecticut, United States

Laurel, Delaware, United States

Newark, Delaware, United States

Washington D.C., District of Columbia, United States

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

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 Falls, Idaho, United States

Pocatello, Idaho, United States

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

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

Davenport, Iowa, United States

Waterloo, Iowa, United States

Overland Park, Kansas, United States

Elizabethtown, Kentucky, United States

Louisville, Kentucky, United States

Mount Sterling, Kentucky, United States

Alexandria, Louisiana, United States

Bossier City, Louisiana, United States

Natchitoches, Louisiana, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Rockport, Maine, United States

Annapolis, Maryland, United States

Baltimore, Maryland, United States

Randallstown, Maryland, United States

Salisbury, Maryland, United States

Fall River, Massachusetts, United States

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

Minneapolis, Minnesota, United States

Bridgeton, Missouri, United States

Kansas City, Missouri, United States

Fremont, Nebraska, United States

Las Vegas, Nevada, United States

Reno, Nevada, United States

Nashua, New Hampshire, United States

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 Township, New Jersey, United States

Wayne, New Jersey, United States

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

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

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

Tulsa, Oklahoma, United States

Medford, Oregon, United States

Portland, Oregon, United States

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

Providence, Rhode Island, United States

Warwick, Rhode Island, United States

Woonsocket, Rhode Island, United States

Charleston, South Carolina, United States

Easley, South Carolina, United States

Lancaster, South Carolina, United States

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

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

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

Seattle, Washington, United States

Tacoma, Washington, United States

Vancouver, Washington, United States

Walla Walla, Washington, United States

Charleston, West Virginia, United States

La Crosse, Wisconsin, United States

Milwaukee, Wisconsin, United States

Waukesha, Wisconsin, United States

Wausau, Wisconsin, United States

Río Grande, , Puerto Rico

Charlotte Amalie, , Virgin Islands

Countries

United States; Puerto Rico; Virgin Islands

References

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Other Identifiers

RIVAROXAFL4002

Identifier Type: OTHER

Identifier Source: secondary_id

CR100871

Identifier Type: -

Identifier Source: org_study_id