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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Janssen Scientific Affairs, LLC
Sponsor:
Collaborators:
Duke Clinical Research Institute
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01701817
First received: October 3, 2012
Last updated: April 10, 2017
Last verified: April 2017
  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.


Estimated Enrollment: 15000
Actual Study Start Date: February 20, 2013
Estimated Study Completion Date: February 28, 2018
Estimated Primary Completion Date: February 28, 2018 (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701817

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Alabama
Cullman Clinical Research, LLC Active, not recruiting
Cullman, Alabama, United States, 35058
Eastern Shore Heart Center Completed
Fairhope, Alabama, United States, 36532
Mobile Heart Specialists, PC Active, not recruiting
Mobile, Alabama, United States, 36608
Black Warrior Research Active, not recruiting
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
IMS Cardiology Active, not recruiting
Avondale, Arizona, United States, 85392
Paseo Family Physicians Active, not recruiting
Glendale, Arizona, United States, 85308
Multispecialty Physicians Internal Medicine-CRI Goodyear Active, not recruiting
Goodyear, Arizona, United States, 85395
Scottsdale Healthcare Active, not recruiting
Scottsdale, Arizona, United States, 85258
Multispecialty Physicians Internal Medicine -CRI Sun City Active, not recruiting
Sun Cit, Arizona, United States, 85351
Orange Grove Family Practice Clinical Research Advantage, Inc. Active, not recruiting
Tucson, Arizona, United States, 85741
United States, California
Long Life Cardiac Center Active, not recruiting
Alhambra, California, United States, 91801
Cardiology Consultants of Orange County Active, not recruiting
Anaheim, California, United States, 92801
Comprehensive Cardiovascular Medical Group_Bakersfield Active, not recruiting
Bakersfield, California, United States, 93309
Beaver Medical Group/ Care Clinical Research Corporation Active, not recruiting
Banning, California, United States, 92220
Med Institute, Inc./Mobile Physician Associates/National ACO, LLC Active, not recruiting
Beverly Hills, California, United States, 90210
Cassidy Medical Group/Clinical Research Advantage Active, not recruiting
Carlsbad, California, United States, 92008
John Muir Physician Network Clinical Research Center Active, not recruiting
Concord, California, United States, 94520
Sillicon Valley Cardiology Medical Group Active, not recruiting
E Palo Alto, California, United States, 94303
Cardiovascular Consultants Heart Center Active, not recruiting
Fresno, California, United States, 93720
California Heart Specialists, Inc Active, not recruiting
Huntington Beach, California, United States, 92648
Alliance Clinical Research Completed
Laguna Hills, California, United States, 92653
Larkspur Cardiologists Active, not recruiting
Larkspur, California, United States, 94939
HealthCare Partners Long Beach Active, not recruiting
Long Beach, California, United States, 90806
Cardiovascular Innovation and Research Active, not recruiting
Long Beach, California, United States, 90813
Los Alamitos Cardiovascular Active, not recruiting
Los Alamitos, California, United States, 90720
Healthcare Partners Medical Group Recruiting
Los Angeles, California, United States, 90015
Metabolic Clinic and Research Center Completed
Los Angeles, California, United States, 90033
COR Healthcare Medical Associates - Manhattan Beach Active, not recruiting
Manhattan Beach, California, United States, 90266
HealthCare Partners Medical Grp Active, not recruiting
Mission Hills, California, United States, 91345
Pacific Coast Cardiology and Research Completed
Newport Beach, California, United States, 92663
Valley Clinical Trials, Inc. Active, not recruiting
Northridge, California, United States, 91325
Foothill Cardiology Active, not recruiting
Pasadena, California, United States, 91105
HealthCarePartners Del Mar Active, not recruiting
Pasadena, California, United States, 91105
California Cardiovascular Care Med Group Active, not recruiting
Pasadena, California, United States, 91107
Indus Clinical Research Institute Active, not recruiting
Pomona, California, United States, 91767
Alliance Clinical Research-Poway Active, not recruiting
Poway, California, United States, 92064
Eisenhower Desert Cardiology Center Active, not recruiting
Rancho Mirage, California, United States, 92270
COR Healthcare Medical Associates Active, not recruiting
San Pedro, California, United States, 90732
Private Practice - T.Vasiliauskas Active, not recruiting
Santa Rosa, California, United States, 95405
iCardiology/California Hospital Medical Center Active, not recruiting
Torrance, California, United States, 90274
Harbor Ucla Medical Center Active, not recruiting
Torrance, California, United States, 90502
Torrance Memorial Medical Center Active, not recruiting
Torrance, California, United States, 90505
HealthCare Partners Torrence Specialty Office Active, not recruiting
Torrence, California, United States, 90503
Ventura Cardiology Consultants Medical Group Inc. Active, not recruiting
Ventura, California, United States, 93003
United States, Colorado
University of Colorado Denver Active, not recruiting
Aurora, Colorado, United States, 80045
Colorado Cardiac Alliance, LLC Active, not recruiting
Colorado Springs, Colorado, United States, 80907
Pikes Peak Cardiology Active, not recruiting
Colorado Springs, Colorado, United States, 80909
Colorado Springs Health Partners/Clinical Research Advantage Active, not recruiting
Colorado Springs, Colorado, United States, 80920
Colorado Heart and Vascular, PC Active, not recruiting
Lakewood, Colorado, United States, 80228
United States, Connecticut
Bridgeport Hospital Active, not recruiting
Bridgeport, Connecticut, United States, 06610
Cardiology Associates of New Haven Active, not recruiting
Guilford, Connecticut, United States, 06437
United States, Delaware
Southern Delaware Research Consulting, Inc. Active, not recruiting
Laurel, Delaware, United States, 19956
Alfieri Cardiology Active, not recruiting
Newark, Delaware, United States, 19713
United States, District of Columbia
Veterans Affairs Medical Center, Washington, DC Active, not recruiting
Washington, District of Columbia, United States, 20422
United States, Florida
Bay Pines VA Healthcare System Active, not recruiting
Bay Pines, Florida, United States, 33744
Pinellas Arrhythmia Associates Active, not recruiting
Clearwater, Florida, United States, 33756
Holly Cross Medical Group Active, not recruiting
Coral Springs, Florida, United States, 33065
Lake Internal Medicine Associates Active, not recruiting
Eustis, Florida, United States, 32726
TFPS Active, not recruiting
Jupiter, Florida, United States, 33458
Watson Clinic Llp Active, not recruiting
Lakeland, Florida, United States, 33805
LCC Medical Research Institute, Inc Completed
Miami, Florida, United States, 33126
Life Spring Research Foundation Active, not recruiting
Miami, Florida, United States, 33134
Suncoast Research Group Completed
Miami, Florida, United States, 33135
Jackson Health System Active, not recruiting
Miami, Florida, United States, 33136
Blue Oceans Research - Miami Completed
Miami, Florida, United States, 33144
Phoenix Medical Research, LLC Active, not recruiting
Miami, Florida, United States, 33174
South Florida Research Group Active, not recruiting
Miami, Florida, United States, 33176
South Florida Research Solutions LLC Active, not recruiting
Miramar, Florida, United States, 33025
Palm Harbor Medical Associates Active, not recruiting
Palm Harbor, Florida, United States, 34684
Cardiology Consultants - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32501
Charlotte Heart Group Research Center Active, not recruiting
Port Charlotte, Florida, United States, 33952
University of South Florida Active, not recruiting
Tampa, Florida, United States, 33606
Cardiology Partners Clinical Research Institute Completed
Wellington, Florida, United States, 33449
United States, Georgia
Atlanta Cardiology Consultants Active, not recruiting
Alpharetta, Georgia, United States, 30005
Athens Regional Medical Center Active, not recruiting
Athens, Georgia, United States, 30606
Cardiology of Atlanta Completed
Atlanta, Georgia, United States, 30328
Atlanta Heart Specialists LLC Active, not recruiting
Cumming, Georgia, United States, 30041
Northeast Georgia Heart Center Active, not recruiting
Gainesville, Georgia, United States, 30501
Georgia Arrhythmia Consultants and Research Institute Active, not recruiting
Macon, Georgia, United States, 31201
WellStar Health System Active, not recruiting
Marietta, Georgia, United States, 30060
Redmond Regional Med Active, not recruiting
Rome, Georgia, United States, 30165
Atlanta Vanguard Medical Associates Active, not recruiting
Smyrna, Georgia, United States, 30082
United States, Idaho
Eastern Idaho Medical Consultants Active, not recruiting
Idaho Falls, Idaho, United States, 83404
Idaho State University Active, not recruiting
Pocatello, Idaho, United States, 83201
United States, Illinois
Fox Valley Clinical Research Center LLC Active, not recruiting
Aurora, Illinois, United States, 60504
Edward Hines Jr V A Hospital Completed
Hines, Illinois, United States, 60141
Consultants in Cardiovascular Medicine Active, not recruiting
Melrose Park, Illinois, United States, 60160
Heartland Cardiovascular Center, LLC Active, not recruiting
New Lenox, Illinois, United States, 60451
Captain James A Lovell Federal Health Care Center Active, not recruiting
North Chicago, Illinois, United States, 60064
Methodist Medical Group - Cardiology Completed
Peoria, Illinois, United States, 61606
Advanced Cardiovascular Consultants Active, not recruiting
Rock Island, Illinois, United States, 61201
United States, Indiana
Community Hospital of Anderson & Madison County, Inc. Active, not recruiting
Anderson, Indiana, United States, 46011
Premier Healthcare LLC Active, not recruiting
Bloomington, Indiana, United States, 47403
Cardiology Associates of Northwest Indiana PC Active, not recruiting
Hammond, Indiana, United States, 46320
Franciscan Physician Network-Indiana Heart Physicians Active, not recruiting
Indianapolis, Indiana, United States, 46237
Memorial Health System, Inc d/b/a LaPorte Medical Group Active, not recruiting
La Porte, Indiana, United States, 46350
Cardiovascular Research of Northwest Indiana Active, not recruiting
Munster, Indiana, United States, 46321
Cardiology Associates Incorporated Active, not recruiting
South Bend, Indiana, United States, 46601
Memorial Hospital-other Active, not recruiting
South Bend, Indiana, United States, 46601
United States, Iowa
Midwest Cardiovascular Research Foundation Active, not recruiting
Davenport, Iowa, United States, 52803
Northeast Iowa Medical Education Foundation Active, not recruiting
Waterloo, Iowa, United States, 50702
United States, Kansas
Midwest Cardiology Associates Active, not recruiting
Overland Park, Kansas, United States, 66209
United States, Kentucky
Central Cardiology Associates Active, not recruiting
Elizabethtown, Kentucky, United States, 42701
Norton Cardiovascular Associates Active, not recruiting
Louisvile, Kentucky, United States, 40205
United States, Louisiana
Cambridge Medical Trials Active, not recruiting
Alexandria, Louisiana, United States, 71301
Grace Research, LLC - Bossier City Active, not recruiting
Bossier City, Louisiana, United States, 71111
KAMP Medical Research, Inc Active, not recruiting
Natchitoches, Louisiana, United States, 71457
Anand Irimpen Active, not recruiting
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center Active, not recruiting
New Orleans, Louisiana, United States, 70112
Cardiovascular Research, LLC Active, not recruiting
Shreveport, Louisiana, United States, 71105
United States, Maine
Penobscot Bay Medical Center Active, not recruiting
Rockport, Maine, United States, 04841
United States, Maryland
Anne Arundel Health System Research Institute Completed
Annapolis, Maryland, United States, 21401
The Johns Hopkins Univeristy Active, not recruiting
Baltimore, Maryland, United States, 21205
Sinai Hospital of Baltimore Active, not recruiting
Baltimore, Maryland, United States, 21215
Northwest Hospital Center of Baltimore Active, not recruiting
Randallstown, Maryland, United States, 21133
Peninsula Cardiology Associates Active, not recruiting
Salisbury, Maryland, United States, 21804
United States, Massachusetts
NECCR Internal Medicine and Cardiology, LLC Completed
Fall River, Massachusetts, United States, 02720
United States, Michigan
Endeavor Medical Research Active, not recruiting
Alpena, Michigan, United States, 49707
Bay Regional Medical Center Active, not recruiting
Bay City, Michigan, United States, 48708
Cardiology Institute of Michigan Active, not recruiting
Flint, Michigan, United States, 48507
Genesys Reg Medical Cntr-surgery-general Active, not recruiting
Grand Blanc, Michigan, United States, 48439
Thoracic & Cardiovascular Heatlhcare Foundation Active, not recruiting
Lansing, Michigan, United States, 48910
Cardiology Consultants of East Michigan Active, not recruiting
Lapeer, Michigan, United States, 48446
McLaren-Macomb Active, not recruiting
Mount Clemens, Michigan, United States, 48043
Academic Cardiology Associates Active, not recruiting
Rochester Hills, Michigan, United States, 48307
Great Lakes Heart & Vascular Institute Active, not recruiting
St. Joseph, Michigan, United States, 49085
Munson Med Ctr/phcy Active, not recruiting
Traverse City, Michigan, United States, 49684
Beaumont Health System Active, not recruiting
Troy, Michigan, United States, 48085
Michigan Heart & Vascular Institute Active, not recruiting
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minneapolis Heart Institute Foundation Active, not recruiting
Minneapolis, Minnesota, United States, 55407
United States, Missouri
West Florissant Internists/Clinical Research Advantage, Inc. Active, not recruiting
Bridgeton, Missouri, United States, 63044
Truman Medical Ctr-west Active, not recruiting
Kansas City, Missouri, United States, 64108
United States, Nebraska
Prairie Fields Family Medicine/Clinical Research Advantage Completed
Fremont, Nebraska, United States, 68025
United States, Nevada
Clinical Research of South Nevada Completed
Las Vegas, Nevada, United States, 89121
CIMA Medical Research Inc. Completed
Las Vegas, Nevada, United States, 89146
St Mary's Regional Medical Center Active, not recruiting
Reno, Nevada, United States, 89503
United States, New Hampshire
Lahey Cardiology at the Medical Center Active, not recruiting
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Advanced Heart Care, LLC Active, not recruiting
Bridgewater, New Jersey, United States, 08807
Cardiology Associates of Somerset County Active, not recruiting
Bridgewater, New Jersey, United States, 08807
Rakesh K Passi, MD LLC Active, not recruiting
East Brunswick, New Jersey, United States, 08816
Hunterdon Cardiovascular Associates Active, not recruiting
Flemington, New Jersey, United States, 08822
NJ Heart Active, not recruiting
Linden, New Jersey, United States, 07036
JPAZ Perfection Clinical, LLC Active, not recruiting
Manalapan, New Jersey, United States, 07726
Virtua Medical Group, P.A. d/b/a Virtua Cardiology Group Active, not recruiting
Moorestown, New Jersey, United States, 08057
Lakeland Cardiology Active, not recruiting
Mountain Lakes, New Jersey, United States, 07046
Cardio Metabolic Institute Active, not recruiting
Somerset, New Jersey, United States, 08873
Cardiology Consultants Active, not recruiting
Toms River, New Jersey, United States, 08755
Virtua Medical Group, P.A. d/b/a Virtua Cardiology Group Completed
Voorhees, New Jersey, United States, 08043
Cardiology Associates of North Jersey Active, not recruiting
Wayne, New Jersey, United States, 07470
United States, New York
Samuel S. Stratton Verterans Affairs Medical Center Active, not recruiting
Albany, New York, United States, 12208
The New York Hospital Center of Queens Active, not recruiting
Flushing, New York, United States, 11355
Huntington Hospital Completed
Huntington, New York, United States, 11743
Smart Medical Research Active, not recruiting
Jackson Heights, New York, United States, 11372
Jamaica Hospital Med Ctr Active, not recruiting
Jamaica, New York, United States, 11418
Jamestown Area Medical Associates Healthcare Active, not recruiting
Jamestown, New York, United States, 14701
Long Island Cardiovascular Imaging Consultants Active, not recruiting
Lake Success, New York, United States, 11042
Long Island Heart Associates Active, not recruiting
Mineola, New York, United States, 11501
Northern Westchester Hospital Active, not recruiting
Mount Kisco, New York, United States, 10549
Manhattan Medical Research Active, not recruiting
New York, New York, United States, 10016
DiGiovanna Institute for Medical Education & Research Completed
North Massapequa, New York, United States, 11758
Central New York Cardiology Active, not recruiting
Utica, New York, United States, 13501
St. Elizabeth Medical Center Active, not recruiting
Utica, New York, United States, 13501
United States, North Carolina
Kernodle Clinic Completed
Burlington, North Carolina, United States, 27215
UNC Center for Heart and Vascular Care Active, not recruiting
Chapel, North Carolina, United States, 27599
Durham VAMC Active, not recruiting
Durham, North Carolina, United States, 27705
Eastern Carolina Cardiovascular Active, not recruiting
Elizabeth City, North Carolina, United States, 27909
LeBauer Cardiovascular Research Foundation at CONE Health Active, not recruiting
Greensboro, North Carolina, United States, 27401
Pinehurst Medical Clinic Active, not recruiting
Pinehurst, North Carolina, United States, 28374
Family Medical Associates of Raleigh Recruiting
Raleigh, North Carolina, United States, 27609
Sanford Cardiology Active, not recruiting
Sanford, North Carolina, United States, 27330
Palmetto Research Center Active, not recruiting
Spartanburg, North Carolina, United States, 29302
United States, Ohio
Aultman Hospital Active, not recruiting
Canton, Ohio, United States, 44710
Louis Stokes Cleveland VA Med Ctr Active, not recruiting
Cleveland, Ohio, United States, 44106
Ohio Health Active, not recruiting
Columbus, Ohio, United States, 43215
Mid-Ohio Heart Clinic Active, not recruiting
Mansfield, Ohio, United States, 44906
Mound Family Practice Associates Active, not recruiting
Miamisburg, Ohio, United States, 45342
Northwest Ohio Cardiology Consultants Active, not recruiting
Toledo, Ohio, United States, 43615
Central Ohio Primary Care Physicians Inc. Active, not recruiting
Worthington, Ohio, United States, 43085
St. Elizabeth Health Center Completed
Youngstown, Ohio, United States, 44504
United States, Oklahoma
Oklahoma Heart Institute Active, not recruiting
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Southern Oregon Cardiology, LLC Active, not recruiting
Medford, Oregon, United States, 97504
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Abington Medical Specialists Active, not recruiting
Abington, Pennsylvania, United States, 19001
St. Vincent Medical Group, Inc. Active, not recruiting
Abington, Pennsylvania, United States, 46260
Chambersburg Hospital Active, not recruiting
Chambersburg, Pennsylvania, United States, 17201
Central Bucks Cardiology, VIAA Active, not recruiting
Doylestown, Pennsylvania, United States, 18901
Doylestown Cardiology Associates-VIAA Active, not recruiting
Doylestown, Pennsylvania, United States, 18901
Physician Specialists of N. Lancaster County Medical Group - Heart Specialists of Lancaster County Active, not recruiting
Ephrata, Pennsylvania, United States, 17522
Comprehensive Cardiology Consultants Active, not recruiting
Langhorne, Pennsylvania, United States, 19047
Detweiler Family Medicine and Associates Active, not recruiting
Lansdale, Pennsylvania, United States, 19446
Jefferson Coordinating Center for Clinical Research Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Drexel University College of Medicine Active, not recruiting
Phildelphia, Pennsylvania, United States, 19102
Donald Guthrie Foundation for Education and Research, Inc. Active, not recruiting
Sayre, Pennsylvania, United States, 18840
Reading Hospital Active, not recruiting
West Reading, Pennsylvania, United States, 19611
Lankenau Institute for Medical Research Active, not recruiting
Wynnewood, Pennsylvania, United States, 19096
Cardiology Consultants of Philadelphia Active, not recruiting
Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
The Miriam Hospital Active, not recruiting
Providence, Rhode Island, United States, 02906
Adnab Research Inc. - Elgabry Active, not recruiting
Warwick, Rhode Island, United States, 02886
Adnab Research Inc. - Saber Active, not recruiting
Woonsocket, Rhode Island, United States, 02895
United States, South Carolina
Ralph H Johnson Veterans Hospital Active, not recruiting
Charleston, South Carolina, United States, 29401
Einstein Clinical Research Center Active, not recruiting
Lancaster, South Carolina, United States, 29720
United States, Tennessee
PMG Research of Bristol Completed
Bristol, Tennessee, United States, 37620
The Jackson Clinic, PA Active, not recruiting
Jackson, Tennessee, United States, 38305
Holston Medical Group Active, not recruiting
Kingsport, Tennessee, United States, 37660
Mountain Region Family Medicine Completed
Kingsport, Tennessee, United States, 37660
Wellmont Holston Valley Medical Center Active, not recruiting
Kingsport, Tennessee, United States, 37660
University of Tennessee Health Science Center Active, not recruiting
Memphis, Tennessee, United States, 38104
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
Parkway Cardiology Associates PC Active, not recruiting
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Seton Heart Institute Active, not recruiting
Austin, Texas, United States, 78705
Texas Cardiac Arrhythmia Research Foundation Active, not recruiting
Austin, Texas, United States, 78705
Austin Heart PLLC Active, not recruiting
Austin, Texas, United States, 78756
Southeast Texas Clinical Research Center Active, not recruiting
Beaumont, Texas, United States, 77702
Cardiology Associates of Corpus Christi Active, not recruiting
Corpus Christi, Texas, United States, 78404
VA North Texas Health Care System Active, not recruiting
Dallas, Texas, United States, 75216
Brooke Army Medical Center Active, not recruiting
Fort Sam Houston, Texas, United States, 78234
Amir Malik Research Active, not recruiting
Fort Worth, Texas, United States, 76104
Texas Health Physicians Group Active, not recruiting
Ft. Worth, Texas, United States, 76107
Angiocardiac Care of Texas, PA Active, not recruiting
Houston, Texas, United States, 77025
Jimin Wang, MD, PA Active, not recruiting
Houston, Texas, United States, 77036
Dairy Ashford Family Practice Active, not recruiting
Houston, Texas, United States, 77077
Cardiology Center of Houston, PA Active, not recruiting
Katy, Texas, United States, 77450
West Memorial Family Practice Completed
Katy, Texas, United States, 77450
Cardiac Center of Texas PA Active, not recruiting
Mckinney, Texas, United States, 75069
Permian Research Foundation Active, not recruiting
Odessa, Texas, United States, 79761
Grace Research, LLC - Palestine Active, not recruiting
Palestine, Texas, United States, 75801
Plano Internal Medicine Associates Clinical Research Advantage, Inc. Completed
Plano, Texas, United States, 75093
Scott & White Healthcare Active, not recruiting
Round Rock, Texas, United States, 78665
Cardiac Center of San Antonio Active, not recruiting
San Antonio, Texas, United States, 78205
Lone Star Heart and Vascular Care Center Active, not recruiting
Tomball, Texas, United States, 77375
Northwest Houston Clinical Research Active, not recruiting
Tomball, Texas, United States, 77375
Tyler Cardiovascular Consultants Active, not recruiting
Tyler, Texas, United States, 75701
United States, Virginia
Dominion Biomedical Research Alliance, Inc. Active, not recruiting
Annandale, Virginia, United States, 22003
Centra Health Cardiovascular Group Active, not recruiting
Lynchburg, Virginia, United States, 24501
Richmond Cardiology Associates Active, not recruiting
Mechanicsville, Virginia, United States, 23116
Cardiovascular Associates of Virginia Active, not recruiting
Midlothian, Virginia, United States, 23114
Riverside Cardiology Specialists Active, not recruiting
Newport News, Virginia, United States, 23601
Cardiovascular Associates, Ltd. Active, not recruiting
Virginia Beach, Virginia, United States, 23454
United States, Washington
University of Washington Completed
Seattle, Washington, United States, 98195
Multicare Health Systems Active, not recruiting
Tacoma, Washington, United States, 98405
Universal Research Group, LLC Active, not recruiting
Tacoma, Washington, United States, 98405
Northwest Medical Associates P.S. -222 NE Park Plaza Dr. Active, not recruiting
Vancouver, Washington, United States, 98684
Walla Walla Clinic Active, not recruiting
Walla Walla, Washington, United States, 99362
United States, West Virginia
CAMC Clinical Trials Center Active, not recruiting
Charleston, West Virginia, United States, 25304
Charleston Internal Medicine Completed
Charleston, West Virginia, United States, 25304
United States, Wisconsin
FSH/Mayo Health System Active, not recruiting
La Crosse, Wisconsin, United States, 54601
Aurora Saint Lukes Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
ProHealth Care Active, not recruiting
Waukesha, Wisconsin, United States, 53188
Aspirus Heart & Vascular Institute-Research & Education Active, not recruiting
Wausau, Wisconsin, United States, 54401
Puerto Rico
Denis Ruiz Serrano Cardologia Active, not recruiting
Rio Grande, Puerto Rico, 00745
Virgin Islands (U.S.)
Virgin Islands Heart Active, not recruiting
St. Thomas, Virgin Islands (U.S.), 00802
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

Additional 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 )
Study First Received: October 3, 2012
Last Updated: April 10, 2017

Studies a U.S. FDA-regulated Drug Product: Yes

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

ClinicalTrials.gov processed this record on April 21, 2017