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Atrial FibrillationORBIT-AF IINCT01701817

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

An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 219 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Patients with Atrial Fibrillation
How many people
13,769 participants
Where
219 sitesin 3 countries
Study dates
20 Feb 2013to 12 Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Enrolling physicians will include cardiologists, internists, and electrophysiologists from both academic and private practice who preferably have experience in registry participation.

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

219 sites in 3 countries.

219 sites in 3 countries

United States217 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Albany, New York

  • Study site

    Alexandria, Louisiana

  • Study site

    Alhambra, California

  • Study site

    Alpena, Michigan

  • Study site

    Alpharetta, Georgia

  • Study site

    Anaheim, California

  • Study site

    Anderson, Indiana

  • Study site

    Annandale, Virginia

  • Study site

    Annapolis, Maryland

  • Study site

    Athens, Georgia

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Aurora, Illinois

  • Study site

    Austin, Texas

  • Study site

    Avondale, Arizona

  • Study site

    Bakersfield, California

  • Study site

    Baltimore, Maryland

  • Study site

    Banning, California

  • Study site

    Bay City, Michigan

  • Study site

    Bay Pines, Florida

  • Study site

    Beaumont, Texas

  • Study site

    Beverly Hills, California

  • Study site

    Bloomington, Indiana

  • Study site

    Bossier City, Louisiana

  • Study site

    Bridgeport, Connecticut

  • Study site

    Bridgeton, Missouri

  • Study site

    Bridgewater, New Jersey

  • Study site

    Bristol, Tennessee

  • Study site

    Burlington, North Carolina

  • Study site

    Canton, Ohio

  • Study site

    Carlsbad, California

  • Study site

    Chambersburg, Pennsylvania

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charleston, West Virginia

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Concord, California

  • Study site

    Coral Springs, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Cullman, Alabama

  • Study site

    Cumming, Georgia

  • Study site

    Dallas, Texas

  • Study site

    Davenport, Iowa

  • Study site

    Dothan, Alabama

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    Easley, South Carolina

  • Study site

    East Brunswick, New Jersey

  • Study site

    East Palo Alto, California

  • Study site

    Elizabeth City, North Carolina

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Ephrata, Pennsylvania

  • Study site

    Eustis, Florida

  • Study site

    Fairhope, Alabama

  • Study site

    Fall River, Massachusetts

  • Study site

    Flemington, New Jersey

  • Study site

    Flint, Michigan

  • Study site

    Flushing, New York

  • Study site

    Fort Sam Houston, Texas

  • Study site

    Fort Worth, Texas

  • Study site

    Fremont, Nebraska

  • Study site

    Fresno, California

  • Study site

    Gainesville, Georgia

  • Study site

    Glendale, Arizona

  • Study site

    Goodyear, Arizona

  • Study site

    Grand Blanc, Michigan

  • Study site

    Greensboro, North Carolina

  • Study site

    Guilford, Connecticut

  • Study site

    Hammond, Indiana

  • Study site

    Hines, Illinois

  • Study site

    Houston, Texas

  • Study site

    Huntington, New York

  • Study site

    Huntington Beach, California

  • Study site

    Idaho Falls, Idaho

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Tennessee

  • Study site

    Jackson Heights, New York

  • Study site

    Jamaica, New York

  • Study site

    Jamestown, New York

  • Study site

    Jupiter, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Katy, Texas

  • Study site

    Kingsport, Tennessee

  • Study site

    La Crosse, Wisconsin

  • Study site

    La Porte, Indiana

  • Study site

    Laguna Hills, California

  • Study site

    Lake Success, New York

  • Study site

    Lakeland, Florida

  • Study site

    Lakewood, Colorado

  • Study site

    Lancaster, South Carolina

  • Study site

    Langhorne, Pennsylvania

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Lapeer, Michigan

  • Study site

    Larkspur, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Laurel, Delaware

  • Study site

    Linden, New Jersey

  • Study site

    Long Beach, California

  • Study site

    Los Alamitos, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lynchburg, Virginia

  • Study site

    Macon, Georgia

  • Study site

    Manalapan, New Jersey

  • Study site

    Manhattan Beach, California

  • Study site

    Mansfield, Ohio

  • Study site

    Marietta, Georgia

  • Study site

    McKinney, Texas

  • Study site

    Mechanicsville, Virginia

  • Study site

    Medford, Oregon

  • Study site

    Melrose Park, Illinois

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Miamisburg, Ohio

  • Study site

    Midlothian, Virginia

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mineola, New York

  • Study site

    Minneapolis, Minnesota

  • Study site

    Miramar, Florida

  • Study site

    Mission Hills, California

  • Study site

    Mobile, Alabama

  • Study site

    Moorestown, New Jersey

  • Study site

    Mount Clemens, Michigan

  • Study site

    Mount Kisco, New York

  • Study site

    Mount Sterling, Kentucky

  • Study site

    Mountain Lakes, New Jersey

  • Study site

    Munster, Indiana

  • Study site

    Nashua, New Hampshire

  • Study site

    Nashville, Tennessee

  • Study site

    Natchitoches, Louisiana

  • Study site

    New Lenox, Illinois

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Newport Beach, California

  • Study site

    Newport News, Virginia

  • Study site

    North Chicago, Illinois

  • Study site

    North Massapequa, New York

  • Study site

    Northridge, California

  • Study site

    Oak Ridge, Tennessee

  • Study site

    Odessa, Texas

  • Study site

    Overland Park, Kansas

  • Study site

    Palestine, Texas

  • Study site

    Palm Harbor, Florida

  • Study site

    Pasadena, California

  • Study site

    Pensacola, Florida

  • Study site

    Peoria, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pinehurst, North Carolina

  • Study site

    Pismo Beach, California

  • Study site

    Plano, Texas

  • Study site

    Pocatello, Idaho

  • Study site

    Pomona, California

  • Study site

    Port Charlotte, Florida

  • Study site

    Portland, Oregon

  • Study site

    Poway, California

  • Study site

    Providence, Rhode Island

  • Study site

    Rancho Mirage, California

  • Study site

    Randallstown, Maryland

  • Study site

    Reno, Nevada

  • Study site

    Rochester Hills, Michigan

  • Study site

    Rock Island, Illinois

  • Study site

    Rockport, Maine

  • Study site

    Rome, Georgia

  • Study site

    Round Rock, Texas

  • Study site

    Saint Joseph, Michigan

  • Study site

    Salisbury, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Pedro, California

  • Study site

    Sanford, North Carolina

  • Study site

    Santa Rosa, California

  • Study site

    Sayre, Pennsylvania

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Shreveport, Louisiana

  • Study site

    Smyrna, Georgia

  • Study site

    Somerset, New Jersey

  • Study site

    South Bend, Indiana

  • Study site

    Spartanburg, North Carolina

  • Study site

    Sun City, Arizona

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Tomball, Texas

  • Study site

    Toms River, New Jersey

  • Study site

    Torrance, California

  • Study site

    Traverse City, Michigan

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Tyler, Texas

  • Study site

    Utica, New York

  • Study site

    Vancouver, Washington

  • Study site

    Ventura, California

  • Study site

    Virginia Beach, Virginia

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Walla Walla, Washington

  • Study site

    Warwick, Rhode Island

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Waterloo, Iowa

  • Study site

    Waukesha, Wisconsin

  • Study site

    Wausau, Wisconsin

  • Study site

    Wayne, New Jersey

  • Study site

    Wellington, Florida

  • Study site

    West Reading, Pennsylvania

  • Study site

    Woonsocket, Rhode Island

  • Study site

    Worthington, Ohio

  • Study site

    Wynnewood, Pennsylvania

  • Study site

    Yardley, Pennsylvania

  • Study site

    Youngstown, Ohio

  • Study site

    Ypsilanti, Michigan

Other trials in United States

Puerto Rico1 site

  • Study site

    Rio Grande

Other trials in Puerto Rico

Virgin Islands1 site

  • Study site

    Charlotte Amalie

About this study

Official title: 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.

Read the 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).

Being tested
Patients with Atrial Fibrillation
Keywords
Atrial Fibrillation, Irregular heart beat
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients with Atrial FibrillationOther

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

Study groups in NCT01701817
Study groupRoleWhat they receive
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.
Receives: Other: Patients with Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of major bleeding events

    Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.

    Measured: 2 years

Secondary outcomes (1)

  1. Number of major adverse cardiac events

    Major cardiac events are defined as stroke or non-central nervous system (non-CNS) systemic embolism, myocardial infarction, and cardiovascular death.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2012 (estimated)
  2. Study start20 Feb 2013
  3. Primary completion12 Jul 2017
  4. Study completion12 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
13,769 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701817
Sponsor's protocol ID
CR100871
Other IDs
RIVAROXAFL4002
Acronym
ORBIT-AF II
Status last verified
Jan 2025
First submitted
3 Oct 2012
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No

Publications

  • Fox KAA, Virdone S, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Oto A, Misselwitz F, Piccini JP, Dalgaard F, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.

    PubMed 33892489

  • Jackson LR 2nd, Kim S, Blanco R, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Go AS, Kowey PR, Mahaffey KW, Hylek EM, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II. Discontinuation rates of warfarin versus direct acting oral anticoagulants in US clinical practice: Results from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). Am Heart J. 2020 Aug;226:85-93. doi: 10.1016/j.ahj.2020.04.016. Epub 2020 Apr 28.

    PubMed 32526533

  • Jackson LR 2nd, Kim S, Fonarow GC, Freeman JV, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Singer D, Thomas L, Blanco R, Peterson ED, Piccini JP Sr; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation Patients and Investigators. Stroke Risk and Treatment in Patients with Atrial Fibrillation and Low CHA2DS2-VASc Scores: Findings From the ORBIT-AF I and II Registries. J Am Heart Assoc. 2018 Aug 21;7(16):e008764. doi: 10.1161/JAHA.118.008764.

    PubMed 30369317

  • Inohara T, Kim S, Pieper K, Blanco RG, Allen LA, Fonarow GC, Gersh BJ, Ezekowitz MD, Kowey PR, Reiffel JA, Naccarelli GV, Chan PS, Mahaffey KW, Singer DE, Freeman JV, Steinberg BA, Peterson ED, Piccini JP; ORBIT AF Patients and Investigators. B-type natriuretic peptide, disease progression and clinical outcomes in atrial fibrillation. Heart. 2019 Mar;105(5):370-377. doi: 10.1136/heartjnl-2018-313642. Epub 2018 Sep 18.

    PubMed 30228248

  • Steinberg BA, Shrader P, Pieper K, Thomas L, Allen LA, Ansell J, Chan PS, Ezekowitz MD, Fonarow GC, Freeman JV, Gersh BJ, Kowey PR, Mahaffey KW, Naccarelli GV, Reiffel JA, Singer DE, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) II Investigators. Frequency and Outcomes of Reduced Dose Non-Vitamin K Antagonist Anticoagulants: Results From ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II). J Am Heart Assoc. 2018 Feb 16;7(4):e007633. doi: 10.1161/JAHA.117.007633.

    PubMed 29453305

  • Kaufman BG, Kim S, Pieper K, Allen LA, Gersh BJ, Naccarelli GV, Ezekowitz MD, Fonarow GC, Mahaffey KW, Singer DE, Chan PS, Freeman JV, Ansell J, Kowey PR, Rieffel JA, Piccini J, Peterson E, O'Brien EC. Disease understanding in patients newly diagnosed with atrial fibrillation. Heart. 2018 Mar;104(6):494-501. doi: 10.1136/heartjnl-2017-311800. Epub 2017 Aug 8.

    PubMed 28790169

  • Steinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Hylek E, Kowey PR, Mahaffey KW, O'Brien EC, Singer DE, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Factors associated with non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). Am Heart J. 2017 Jul;189:40-47. doi: 10.1016/j.ahj.2017.03.024. Epub 2017 Apr 4.

    PubMed 28625380

  • Steinberg BA, Simon DN, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Kowey PR, Mahaffey KW, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Management of Major Bleeding in Patients With Atrial Fibrillation Treated With Non-Vitamin K Antagonist Oral Anticoagulants Compared With Warfarin in Clinical Practice (from Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF II]). Am J Cardiol. 2017 May 15;119(10):1590-1595. doi: 10.1016/j.amjcard.2017.02.015. Epub 2017 Mar 28.

    PubMed 28363354

  • Steinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel J, Singer DE, Peterson ED, Piccini JP; ORBIT-AF Investigators and Patients. Off-Label Dosing of Non-Vitamin K Antagonist Oral Anticoagulants and Adverse Outcomes: The ORBIT-AF II Registry. J Am Coll Cardiol. 2016 Dec 20;68(24):2597-2604. doi: 10.1016/j.jacc.2016.09.966.

    PubMed 27978942

  • 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.

    PubMed 25066554

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 219 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 219 sites in United States, Puerto Rico, Virgin Islands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of major bleeding events (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01701817, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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