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
Official title: GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2019-10-15
Enrollment: 11931
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: This a prospective, randomized study in primary care practices.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of all strokes leading to hospitalization
timeFrame: From 2.5 years to 5 years after study start
measure: Incidence of bleeding leading to hospitalization
timeFrame: From 2.5 years to 5 years after study start
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0302
state: Alabama
city: Guntersville
country: United States
facility: Local Institution - 0360
state: Alabama
city: Montgomery
country: United States
facility: Local Institution - 0158
state: Alabama
city: Kingman
country: United States
facility: Local Institution - 0109
state: Arizona
city: Peoria
country: United States
facility: Local Institution - 0047
state: Arizona
city: Peoria
country: United States
facility: Local Institution - 0237
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 0171
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 0271
state: Arizona
city: Yuma
country: United States
facility: Local Institution - 0323
state: Arizona
city: Little Rock
country: United States
facility: Local Institution - 0097
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Fremont
country: United States
facility: Local Institution - 0173
state: California
city: Fullerton
country: United States
facility: Local Institution - 0110
state: California
city: Oakland
country: United States
facility: Local Institution - 0301
state: California
city: Sacramento
country: United States
facility: Local Institution - 0248
state: California
city: Toluca Lake
country: United States
facility: Local Institution - 0061
state: California
city: Aventura
country: United States
facility: Local Institution
state: Florida
city: Boynton Beach
country: United States
facility: Local Institution - 0143
state: Florida
city: Clearwater
country: United States
facility: Local Institution - 0232
state: Florida
city: Clearwater
country: United States
facility: Local Institution - 0017
state: Florida
city: DeLand
country: United States
facility: Local Institution - 0062
state: Florida
city: DeLand
country: United States
facility: University Clinical Research-Deland LLC dba Accel Research Sites
state: Florida
city: Doral
country: United States
facility: Local Institution - 0350
state: Florida
city: Fort Lauderdale
country: United States
facility: Local Institution - 0367
state: Florida
city: Fort Lauderdale
country: United States
facility: Local Institution - 0161
state: Florida
city: Fort Myers
country: United States
facility: Vanguard Clinical Research, LLC
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research Corp
state: Florida
city: Hialeah
country: United States
facility: Local Institution - 0348
state: Florida
city: Hialeah
country: United States
facility: Local Institution - 0358
state: Florida
city: Hialeah
country: United States
facility: Local Institution - 0219
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0366
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0368
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0277
state: Florida
city: Lake City
country: United States
facility: Local Institution - 0375
state: Florida
city: Miami Beach
country: United States
facility: Local Institution - 0149
state: Florida
city: Miami Lakes
country: United States
facility: Local Institution - 0374
state: Florida
city: Miami Shores
country: United States
facility: Local Institution - 0372
state: Florida
city: Miami
country: United States
facility: Nova Clinical Research Center Inc
state: Florida
city: Miami
country: United States
facility: Local Institution - 0025
state: Florida
city: Miami
country: United States
facility: Local Institution - 0296
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution - 0300
state: Florida
city: Miami
country: United States
facility: Local Institution - 0371
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Mount Dora
country: United States
facility: Local Institution - 0010
state: Florida
city: Oviedo
country: United States
facility: Local Institution - 0058
state: Florida
city: Palm Harbor
country: United States
facility: Local Institution - 0132
state: Florida
city: Palm Springs
country: United States
facility: Local Institution - 0034
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0028
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0090
state: Florida
city: Weston
country: United States
facility: Local Institution - 0361
state: Florida
city: Albany
country: United States
facility: Local Institution - 0263
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0027
state: Georgia
city: Columbus
country: United States
facility: Local Institution
state: Georgia
city: Eatonton
country: United States
facility: Local Institution - 0033
state: Georgia
city: Fayetteville
country: United States
facility: Local Institution - 0176
state: Georgia
city: Rincon
country: United States
facility: Local Institution - 0214
state: Georgia
city: Savannah
country: United States
facility: Local Institution - 0098
state: Georgia
city: Woodstock
country: United States
facility: Local Institution - 0123
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0311
state: Illinois
city: Evergreen Park
country: United States
facility: Local Institution - 0345
state: Illinois
city: Gillespie
country: United States
facility: Local Institution - 0241
state: Illinois
city: Wauconda
country: United States
facility: Local Institution - 0306
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 0365
state: Indiana
city: Michigan City
country: United States
facility: Local Institution - 0254
state: Indiana
city: Ames
country: United States
facility: Local Institution - 0338
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Wichita
country: United States
facility: Local Institution - 0244
state: Kansas
city: Lexington
country: United States
facility: Local Institution - 0369
state: Kentucky
city: Eunice
country: United States
facility: Local Institution - 0133
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution - 0321
state: Louisiana
city: Zachary
country: United States
facility: Local Institution - 0229
state: Louisiana
city: Annapolis
country: United States
facility: Local Institution - 0351
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Elkridge
country: United States
facility: Local Institution - 0037
state: Maryland
city: Rockville
country: United States
facility: Local Institution - 0095
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0284
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0051
state: Massachusetts
city: Haverhill
country: United States
facility: Local Institution - 0333
state: Massachusetts
city: New Bedford
country: United States
facility: Local Institution - 0201
state: Massachusetts
city: Worcester
country: United States
facility: Local Institution - 0227
state: Massachusetts
city: Caro
country: United States
facility: Local Institution - 0260
state: Michigan
city: Detroit
country: United States
facility: Local Institution - 0005
state: Michigan
city: Sterling Heights
country: United States
facility: Local Institution - 0166
state: Michigan
city: Troy
country: United States
facility: Local Institution - 0257
state: Michigan
city: Rochester
country: United States
facility: Local Institution - 0256
state: Minnesota
city: Belzoni
country: United States
facility: Belzoni Family Practice
state: Mississippi
city: Jackson
country: United States
facility: Local Institution - 0089
state: Mississippi
city: Petal
country: United States
facility: Local Institution - 0224
state: Mississippi
city: Picayune
country: United States
facility: Local Institution - 0060
state: Mississippi
city: Ridgeland
country: United States
facility: Quinn Healthcare/SKYCRNG
state: Mississippi
city: Saint Louis
country: United States
facility: Local Institution - 0116
state: Missouri
city: Norfolk
country: United States
facility: Local Institution - 0063
state: Nebraska
city: Henderson
country: United States
facility: Local Institution - 0222
state: Nevada
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Linden
country: United States
facility: Local Institution - 0334
state: New Jersey
city: Brooklyn
country: United States
facility: Local Institution - 0249
state: New York
city: Cooperstown
country: United States
facility: Local Institution - 0362
state: New York
city: East Syracuse
country: United States
facility: Local Institution
state: New York
city: Endwell
country: United States
facility: Local Institution - 0102
state: New York
city: Niagara Falls
country: United States
facility: Local Institution - 0379
state: New York
city: North Massapequa
country: United States
facility: Digiovanna Institute For Medical Education
state: New York
city: Black Mountain
country: United States
facility: Local Institution
state: North Carolina
city: Burlington
country: United States
facility: Local Institution - 0328
state: North Carolina
city: Cary
country: United States
facility: Local Institution - 0164
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 0207
state: North Carolina
city: Durham
country: United States
facility: Local Institution - 0006
state: North Carolina
city: Fayetteville
country: United States
facility: Local Institution
state: North Carolina
city: Franklinton
country: United States
facility: Local Institution - 0268
state: North Carolina
city: Greensboro
country: United States
facility: Local Institution - 0258
state: North Carolina
city: Hickory
country: United States
facility: Local Institution - 0159
state: North Carolina
city: Matthews
country: United States
facility: Local Institution - 0331
state: North Carolina
city: Raleigh
country: United States
facility: Local Institution - 0230
state: North Carolina
city: Rocky Mount
country: United States
facility: Local Institution - 0175
state: North Carolina
city: Salisbury
country: United States
facility: Local Institution - 0253
state: North Carolina
city: Statesville
country: United States
facility: Local Institution - 0153
state: North Carolina
city: Statesville
country: United States
facility: Local Institution - 0182
state: North Carolina
city: Wilmington
country: United States
facility: Local Institution - 0235
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 0167
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Cincinnati
country: United States
facility: Local Institution - 0085
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0283
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 0036
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Local Institution - 0212
state: Ohio
city: Philadelphia
country: United States
facility: Local Institution - 0129
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0272
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0236
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0349
state: Pennsylvania
city: Uniontown
country: United States
facility: Local Institution - 0347
state: Pennsylvania
city: Uniontown
country: United States
facility: Local Institution - 0370
state: Pennsylvania
city: East Providence
country: United States
facility: Local Institution - 0240
state: Rhode Island
city: Bristol
country: United States
facility: Local Institution - 0155
state: Tennessee
city: Knoxville
country: United States
facility: Local Institution - 0234
state: Tennessee
city: Morristown
country: United States
facility: Local Institution - 0324
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0309
state: Tennessee
city: Allen
country: United States
facility: Wellness Clinical Research
state: Texas
city: Austin
country: United States
facility: Local Institution - 0187
state: Texas
city: Austin
country: United States
facility: Local Institution - 0243
state: Texas
city: Dallas
country: United States
facility: HRMD Research
state: Texas
city: Denton
country: United States
facility: Local Institution - 0242
state: Texas
city: Edinburg
country: United States
facility: Invesclinic.U.S,LLC
state: Texas
city: Friendswood
country: United States
facility: Local Institution - 0141
state: Texas
city: Georgetown
country: United States
facility: Local Institution - 0354
state: Texas
city: Houston
country: United States
facility: Local Institution - 0011
state: Texas
city: Houston
country: United States
facility: Local Institution - 0343
state: Texas
city: Hurst
country: United States
facility: Local Institution - 0016
state: Texas
city: Laredo
country: United States
facility: Local Institution - 0151
state: Texas
city: Mesquite
country: United States
facility: Local Institution - 0170
state: Texas
city: Pearland
country: United States
facility: Local Institution - 0101
state: Texas
city: Pflugerville
country: United States
facility: Local Institution - 0223
state: Texas
city: Pharr
country: United States
facility: Local Institution - 0303
state: Texas
city: Plano
country: United States
facility: Local Institution - 0204
state: Texas
city: Plano
country: United States
facility: Local Institution - 0067
state: Texas
city: San Antonio
country: United States
facility: SA Premiere Internal Medicine
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0092
state: Texas
city: San Marcos
country: United States
facility: Local Institution - 0278
state: Texas
city: Sugar Land
country: United States
facility: Local Institution - 0055
state: Texas
city: Sugar Land
country: United States
facility: Local Institution - 0137
state: Texas
city: The Woodlands
country: United States
facility: Local Institution - 0251
state: Texas
city: The Woodlands
country: United States
facility: Local Institution - 0147
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0322
state: Texas
city: Bountiful
country: United States
facility: Local Institution - 0150
state: Utah
city: Appomattox
country: United States
facility: Local Institution - 0339
state: Virginia
city: Burke
country: United States
facility: Local Institution - 0191
state: Virginia
city: Forest
country: United States
facility: Local Institution - 0340
state: Virginia
city: Suffolk
country: United States
facility: Local Institution - 0267
state: Virginia
city: Winchester
country: United States
facility: Local Institution - 0096
state: Virginia
city: Winchester
country: United States
facility: Local Institution - 0364
state: Virginia
city: Everett
country: United States
facility: Local Institution - 0086
state: Washington
city: Tacoma
country: United States
facility: Local Institution - 0299
state: Washington
city: Eau Claire
country: United States
facility: Local Institution - 0337
state: Wisconsin
city: La Crosse
country: United States
facility: Local Institution - 0335
state: Wisconsin
city: Madison
country: United States
facility: Local Institution - 0288
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: