- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126486
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke (GUARD-AF)
July 10, 2023 updated by: Bristol-Myers Squibb
GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This a prospective, randomized study in primary care practices.
Study Type
Interventional
Enrollment (Actual)
11931
Phase
- Phase 4
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
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Alabama
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Birmingham, Alabama, United States, 35209
- Local Institution - 0302
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Guntersville, Alabama, United States, 35976
- Local Institution - 0360
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Montgomery, Alabama, United States, 36106
- Local Institution - 0158
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Arizona
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Kingman, Arizona, United States, 86409
- Local Institution - 0109
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Peoria, Arizona, United States, 85381
- Local Institution - 0047
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Peoria, Arizona, United States, 85381
- Local Institution - 0237
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Phoenix, Arizona, United States, 85004
- Local Institution - 0171
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Phoenix, Arizona, United States, 85051
- Local Institution - 0271
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Yuma, Arizona, United States, 85364
- Local Institution - 0323
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Arkansas
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Little Rock, Arkansas, United States, 72204
- Local Institution - 0097
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California
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Canoga Park, California, United States, 91303
- Hope Clinical Research
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Fremont, California, United States, 94538
- Local Institution - 0173
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Fullerton, California, United States, 92831
- Local Institution - 0110
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Oakland, California, United States, 94612
- Local Institution - 0301
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Sacramento, California, United States, 95821-2640
- Local Institution - 0248
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Toluca Lake, California, United States, 91602
- Local Institution - 0061
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Florida
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Aventura, Florida, United States, 33180
- Local Institution
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Boynton Beach, Florida, United States, 33435
- Local Institution - 0143
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Clearwater, Florida, United States, 33756-2004
- Local Institution - 0232
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Clearwater, Florida, United States, 33761
- Local Institution - 0017
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DeLand, Florida, United States, 32720
- Local Institution - 0062
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DeLand, Florida, United States, 32720
- University Clinical Research-Deland LLC dba Accel Research Sites
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Doral, Florida, United States, 33166
- Local Institution - 0350
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Fort Lauderdale, Florida, United States, 33073
- Local Institution - 0367
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Fort Lauderdale, Florida, United States, 33308
- Local Institution - 0161
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Fort Myers, Florida, United States, 33907
- Vanguard Clinical Research, LLC
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Greenacres City, Florida, United States, 33467
- Finlay Medical Research Corp
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Hialeah, Florida, United States, 33012
- Local Institution - 0348
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Hialeah, Florida, United States, 33015
- Local Institution - 0358
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Hialeah, Florida, United States, 33016
- Local Institution - 0219
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Jacksonville, Florida, United States, 32204
- Local Institution - 0366
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Jacksonville, Florida, United States, 32216
- Local Institution - 0368
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Jacksonville, Florida, United States, 32224
- Local Institution - 0277
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Lake City, Florida, United States, 32055-4833
- Local Institution - 0375
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Miami, Florida, United States, 33176
- Local Institution
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Miami, Florida, United States, 33125
- Nova Clinical Research Center Inc
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Miami, Florida, United States, 33144
- Local Institution - 0025
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Miami, Florida, United States, 33144
- Local Institution - 0296
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Miami, Florida, United States, 33155
- Local Institution
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Miami, Florida, United States, 33165
- Local Institution
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Miami, Florida, United States, 33174
- Local Institution - 0300
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Miami, Florida, United States, 33175
- Local Institution - 0371
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Miami Beach, Florida, United States, 33140
- Local Institution - 0149
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Miami Lakes, Florida, United States, 33014
- Local Institution - 0374
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Miami Shores, Florida, United States, 33138
- Local Institution - 0372
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Mount Dora, Florida, United States, 32757-9519
- Local Institution - 0010
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Oviedo, Florida, United States, 32765-4515
- Local Institution - 0058
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Palm Harbor, Florida, United States, 34684
- Local Institution - 0132
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Palm Springs, Florida, United States, 33406
- Local Institution - 0034
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Tampa, Florida, United States, 33613
- Local Institution - 0028
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Tampa, Florida, United States, 33615
- Local Institution - 0090
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Weston, Florida, United States, 33326
- Local Institution - 0361
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Georgia
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Albany, Georgia, United States, 31701
- Local Institution - 0263
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Atlanta, Georgia, United States, 30345
- Local Institution - 0027
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Columbus, Georgia, United States, 31904
- Local Institution
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Eatonton, Georgia, United States, 31024
- Local Institution - 0033
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Fayetteville, Georgia, United States, 30214
- Local Institution - 0176
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Rincon, Georgia, United States, 31406
- Local Institution - 0214
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Savannah, Georgia, United States, 31406
- Local Institution - 0098
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Woodstock, Georgia, United States, 30189
- Local Institution - 0123
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Illinois
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Chicago, Illinois, United States, 60637
- Local Institution - 0311
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Evergreen Park, Illinois, United States, 60805
- Local Institution - 0345
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Gillespie, Illinois, United States, 62033
- Local Institution - 0241
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Wauconda, Illinois, United States, 60084
- Local Institution - 0306
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Indiana
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Indianapolis, Indiana, United States, 46202
- Local Institution - 0365
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Michigan City, Indiana, United States, 46360-9330
- Local Institution - 0254
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Iowa
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Ames, Iowa, United States, 50010
- Local Institution - 0338
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Kansas
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Wichita, Kansas, United States, 67214
- Local Institution - 0244
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Kentucky
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Lexington, Kentucky, United States, 40504
- Local Institution - 0369
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Louisiana
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Eunice, Louisiana, United States, 70535
- Local Institution - 0133
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New Orleans, Louisiana, United States, 70121
- Local Institution - 0321
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Zachary, Louisiana, United States, 70791-4006
- Local Institution - 0229
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Maryland
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Annapolis, Maryland, United States, 21401
- Local Institution - 0351
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Baltimore, Maryland, United States, 21287
- Johns Hopkins
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Elkridge, Maryland, United States, 21075
- Local Institution - 0037
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Rockville, Maryland, United States, 20854
- Local Institution - 0095
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Local Institution - 0284
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Boston, Massachusetts, United States, 02115
- Local Institution - 0051
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Haverhill, Massachusetts, United States, 01830
- Local Institution - 0333
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New Bedford, Massachusetts, United States, 02740
- Local Institution - 0201
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Worcester, Massachusetts, United States, 01655
- Local Institution - 0227
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Michigan
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Caro, Michigan, United States, 48723
- Local Institution - 0260
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Detroit, Michigan, United States, 48216
- Local Institution - 0005
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Sterling Heights, Michigan, United States, 48310
- Local Institution - 0166
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Troy, Michigan, United States, 48085
- Local Institution - 0257
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Minnesota
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Rochester, Minnesota, United States, 55905-0001
- Local Institution - 0256
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Mississippi
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Belzoni, Mississippi, United States, 39038
- Belzoni Family Practice
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Jackson, Mississippi, United States, 39209
- Local Institution - 0089
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Petal, Mississippi, United States, 39465
- Local Institution - 0224
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Picayune, Mississippi, United States, 39466
- Local Institution - 0060
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Ridgeland, Mississippi, United States, 39157
- Quinn Healthcare/SKYCRNG
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Missouri
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Saint Louis, Missouri, United States, 63123
- Local Institution - 0116
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Nebraska
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Norfolk, Nebraska, United States, 68701
- Local Institution - 0063
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Nevada
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Henderson, Nevada, United States, 89014
- Local Institution - 0222
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Las Vegas, Nevada, United States, 89109
- Local Institution
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New Jersey
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Linden, New Jersey, United States, 07036
- Local Institution - 0334
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New York
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Brooklyn, New York, United States, 11229
- Local Institution - 0249
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Cooperstown, New York, United States, 13326
- Local Institution - 0362
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East Syracuse, New York, United States, 13057
- Local Institution
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Endwell, New York, United States, 13760
- Local Institution - 0102
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Niagara Falls, New York, United States, 14304
- Local Institution - 0379
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North Massapequa, New York, United States, 11758
- Digiovanna Institute For Medical Education
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North Carolina
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Black Mountain, North Carolina, United States, 28711
- Local Institution
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Burlington, North Carolina, United States, 27215
- Local Institution - 0328
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Cary, North Carolina, United States, 27615
- Local Institution - 0164
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Charlotte, North Carolina, United States, 28209
- PMG Research of Charlotte, LLC
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Charlotte, North Carolina, United States, 28287
- Local Institution - 0207
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Durham, North Carolina, United States, 27701
- Local Institution - 0006
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Fayetteville, North Carolina, United States, 28304-3571
- Local Institution
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Franklinton, North Carolina, United States, 27525
- Local Institution - 0268
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Greensboro, North Carolina, United States, 27408
- Local Institution - 0258
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Hickory, North Carolina, United States, 28601
- Local Institution - 0159
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Matthews, North Carolina, United States, 28105
- Local Institution - 0331
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Raleigh, North Carolina, United States, 27609
- Local Institution - 0230
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Rocky Mount, North Carolina, United States, 27804
- Local Institution - 0175
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Salisbury, North Carolina, United States, 28144
- Local Institution - 0253
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Statesville, North Carolina, United States, 28625
- Local Institution - 0153
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Statesville, North Carolina, United States, 28625
- Local Institution - 0182
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Wilmington, North Carolina, United States, 28401-7307
- Local Institution - 0235
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Winston-Salem, North Carolina, United States, 27103-4109
- Local Institution - 0167
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Ohio
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Cincinnati, Ohio, United States, 45219
- Sterling Research Group
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Cincinnati, Ohio, United States, 45246
- Local Institution - 0085
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Cleveland, Ohio, United States, 44195
- Local Institution - 0283
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Columbus, Ohio, United States, 43213-3399
- Local Institution - 0036
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Dayton, Ohio, United States, 45406
- Dayton Clinical Research
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Dayton, Ohio, United States, 45419
- Local Institution - 0212
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Local Institution - 0129
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Pittsburgh, Pennsylvania, United States, 15208
- Local Institution - 0272
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Pittsburgh, Pennsylvania, United States, 15236-4604
- Local Institution - 0236
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Pittsburgh, Pennsylvania, United States, 15243
- Local Institution - 0349
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Uniontown, Pennsylvania, United States, 15401
- Local Institution - 0347
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Uniontown, Pennsylvania, United States, 15401
- Local Institution - 0370
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Rhode Island
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East Providence, Rhode Island, United States, 02914
- Local Institution - 0240
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Tennessee
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Bristol, Tennessee, United States, 37620
- Local Institution - 0155
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Knoxville, Tennessee, United States, 37912
- Local Institution - 0234
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Morristown, Tennessee, United States, 37813
- Local Institution - 0324
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Nashville, Tennessee, United States, 37212
- Local Institution - 0309
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Texas
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Allen, Texas, United States, 75013
- Wellness Clinical Research
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Austin, Texas, United States, 78731
- Local Institution - 0187
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Austin, Texas, United States, 78745
- Local Institution - 0243
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Dallas, Texas, United States, 75240
- HRMD Research
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Denton, Texas, United States, 76210
- Local Institution - 0242
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Edinburg, Texas, United States, 78539
- Invesclinic.U.S,LLC
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Friendswood, Texas, United States, 77546
- Local Institution - 0141
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Georgetown, Texas, United States, 78628
- Local Institution - 0354
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Houston, Texas, United States, 77070
- Local Institution - 0011
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Houston, Texas, United States, 77095
- Local Institution - 0343
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Hurst, Texas, United States, 76054-3351
- Local Institution - 0016
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Laredo, Texas, United States, 78041
- Local Institution - 0151
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Mesquite, Texas, United States, 75149
- Local Institution - 0170
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Pearland, Texas, United States, 77584-7401
- Local Institution - 0101
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Pflugerville, Texas, United States, 78660
- Local Institution - 0223
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Pharr, Texas, United States, 78577
- Local Institution - 0303
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Plano, Texas, United States, 75025
- Local Institution - 0204
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Plano, Texas, United States, 75093
- Local Institution - 0067
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San Antonio, Texas, United States, 78220-2531
- SA Premiere Internal Medicine
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San Antonio, Texas, United States, 78249
- Local Institution - 0092
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San Marcos, Texas, United States, 78666-7579
- Local Institution - 0278
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Sugar Land, Texas, United States, 77479
- Local Institution - 0055
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Sugar Land, Texas, United States, 77479
- Local Institution - 0137
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The Woodlands, Texas, United States, 77382
- Local Institution - 0251
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The Woodlands, Texas, United States, 77384
- Local Institution - 0147
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Tyler, Texas, United States, 75702
- Local Institution - 0322
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Utah
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Bountiful, Utah, United States, 84010
- Local Institution - 0150
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Virginia
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Appomattox, Virginia, United States, 24522
- Local Institution - 0339
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Burke, Virginia, United States, 22015
- Local Institution - 0191
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Forest, Virginia, United States, 24551
- Local Institution - 0340
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Suffolk, Virginia, United States, 23435
- Local Institution - 0267
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Winchester, Virginia, United States, 22601
- Local Institution - 0096
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Winchester, Virginia, United States, 22601
- Local Institution - 0364
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Washington
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Everett, Washington, United States, 98208
- Local Institution - 0086
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Tacoma, Washington, United States, 98498
- Local Institution - 0299
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Wisconsin
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Eau Claire, Wisconsin, United States, 54703
- Local Institution - 0337
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La Crosse, Wisconsin, United States, 54601
- Local Institution - 0335
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Madison, Wisconsin, United States, 53715
- Local Institution - 0288
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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
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Men and women at least 70 years of age who are new or established participants in the primary care practice
- Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the Center for Medicare & Medicaid Services (CMS) Medicare Claims Database and to access data from health records
- Health insurance by Medicare Parts A & B (Medicare Fee-for-service)
Exclusion Criteria:
- Oral anticoagulation (OAC) for any indication at the time of enrollment
- History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented in the participant's current medical problem list
- Any condition the investigator considers a contraindication to OAC, e.g., bleeding that required medical attention or severe renal impairment
- Any condition the investigator considers will prevent compliance with study instructions
- Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders)
- History of allergy to adhesive
- Not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
Other protocol-defined inclusion/exclusion criteria could apply
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Zio®XT Monitor Arm
|
A Zio® XT monitor will be affixed to the participant's chest
|
No Intervention: Usual Care Arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of all strokes leading to hospitalization
Time Frame: From 2.5 years to 5 years after study start
|
From 2.5 years to 5 years after study start
|
Incidence of bleeding leading to hospitalization
Time Frame: From 2.5 years to 5 years after study start
|
From 2.5 years to 5 years after study start
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
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.
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)
December 17, 2019
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
July 12, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV185-749
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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-
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-
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