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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This a prospective, randomized study in primary care practices.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11931

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Local Institution - 0302
      • Guntersville, Alabama, United States, 35976
        • Local Institution - 0360
      • Montgomery, Alabama, United States, 36106
        • Local Institution - 0158
    • Arizona
      • Kingman, Arizona, United States, 86409
        • Local Institution - 0109
      • Peoria, Arizona, United States, 85381
        • Local Institution - 0047
      • Peoria, Arizona, United States, 85381
        • Local Institution - 0237
      • Phoenix, Arizona, United States, 85004
        • Local Institution - 0171
      • Phoenix, Arizona, United States, 85051
        • Local Institution - 0271
      • Yuma, Arizona, United States, 85364
        • Local Institution - 0323
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Local Institution - 0097
    • California
      • Canoga Park, California, United States, 91303
        • HOPE Clinical Research
      • Fremont, California, United States, 94538
        • Local Institution - 0173
      • Fullerton, California, United States, 92831
        • Local Institution - 0110
      • Oakland, California, United States, 94612
        • Local Institution - 0301
      • Sacramento, California, United States, 95821-2640
        • Local Institution - 0248
      • Toluca Lake, California, United States, 91602
        • Local Institution - 0061
    • Florida
      • Aventura, Florida, United States, 33180
        • Local Institution
      • Boynton Beach, Florida, United States, 33435
        • Local Institution - 0143
      • Clearwater, Florida, United States, 33756-2004
        • Local Institution - 0232
      • Clearwater, Florida, United States, 33761
        • Local Institution - 0017
      • DeLand, Florida, United States, 32720
        • Local Institution - 0062
      • DeLand, Florida, United States, 32720
        • University Clinical Research-Deland LLC dba Accel Research Sites
      • Doral, Florida, United States, 33166
        • Local Institution - 0350
      • Fort Lauderdale, Florida, United States, 33073
        • Local Institution - 0367
      • Fort Lauderdale, Florida, United States, 33308
        • Local Institution - 0161
      • Fort Myers, Florida, United States, 33907
        • Vanguard Clinical Research, LLC
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research Corp
      • Hialeah, Florida, United States, 33012
        • Local Institution - 0348
      • Hialeah, Florida, United States, 33015
        • Local Institution - 0358
      • Hialeah, Florida, United States, 33016
        • Local Institution - 0219
      • Jacksonville, Florida, United States, 32204
        • Local Institution - 0366
      • Jacksonville, Florida, United States, 32216
        • Local Institution - 0368
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0277
      • Lake City, Florida, United States, 32055-4833
        • Local Institution - 0375
      • Miami, Florida, United States, 33176
        • Local Institution
      • Miami, Florida, United States, 33125
        • Nova Clinical Research Center Inc
      • Miami, Florida, United States, 33144
        • Local Institution - 0025
      • Miami, Florida, United States, 33144
        • Local Institution - 0296
      • Miami, Florida, United States, 33155
        • Local Institution
      • Miami, Florida, United States, 33165
        • Local Institution
      • Miami, Florida, United States, 33174
        • Local Institution - 0300
      • Miami, Florida, United States, 33175
        • Local Institution - 0371
      • Miami Beach, Florida, United States, 33140
        • Local Institution - 0149
      • Miami Lakes, Florida, United States, 33014
        • Local Institution - 0374
      • Miami Shores, Florida, United States, 33138
        • Local Institution - 0372
      • Mount Dora, Florida, United States, 32757-9519
        • Local Institution - 0010
      • Oviedo, Florida, United States, 32765-4515
        • Local Institution - 0058
      • Palm Harbor, Florida, United States, 34684
        • Local Institution - 0132
      • Palm Springs, Florida, United States, 33406
        • Local Institution - 0034
      • Tampa, Florida, United States, 33613
        • Local Institution - 0028
      • Tampa, Florida, United States, 33615
        • Local Institution - 0090
      • Weston, Florida, United States, 33326
        • Local Institution - 0361
    • Georgia
      • Albany, Georgia, United States, 31701
        • Local Institution - 0263
      • Atlanta, Georgia, United States, 30345
        • Local Institution - 0027
      • Columbus, Georgia, United States, 31904
        • Local Institution
      • Eatonton, Georgia, United States, 31024
        • Local Institution - 0033
      • Fayetteville, Georgia, United States, 30214
        • Local Institution - 0176
      • Rincon, Georgia, United States, 31406
        • Local Institution - 0214
      • Savannah, Georgia, United States, 31406
        • Local Institution - 0098
      • Woodstock, Georgia, United States, 30189
        • Local Institution - 0123
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0311
      • Evergreen Park, Illinois, United States, 60805
        • Local Institution - 0345
      • Gillespie, Illinois, United States, 62033
        • Local Institution - 0241
      • Wauconda, Illinois, United States, 60084
        • Local Institution - 0306
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Local Institution - 0365
      • Michigan City, Indiana, United States, 46360-9330
        • Local Institution - 0254
    • Iowa
      • Ames, Iowa, United States, 50010
        • Local Institution - 0338
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Local Institution - 0244
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Local Institution - 0369
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Local Institution - 0133
      • New Orleans, Louisiana, United States, 70121
        • Local Institution - 0321
      • Zachary, Louisiana, United States, 70791-4006
        • Local Institution - 0229
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Local Institution - 0351
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
      • Elkridge, Maryland, United States, 21075
        • Local Institution - 0037
      • Rockville, Maryland, United States, 20854
        • Local Institution - 0095
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0284
      • Boston, Massachusetts, United States, 02115
        • Local Institution - 0051
      • Haverhill, Massachusetts, United States, 01830
        • Local Institution - 0333
      • New Bedford, Massachusetts, United States, 02740
        • Local Institution - 0201
      • Worcester, Massachusetts, United States, 01655
        • Local Institution - 0227
    • Michigan
      • Caro, Michigan, United States, 48723
        • Local Institution - 0260
      • Detroit, Michigan, United States, 48216
        • Local Institution - 0005
      • Sterling Heights, Michigan, United States, 48310
        • Local Institution - 0166
      • Troy, Michigan, United States, 48085
        • Local Institution - 0257
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Local Institution - 0256
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Belzoni Family Practice
      • Jackson, Mississippi, United States, 39209
        • Local Institution - 0089
      • Petal, Mississippi, United States, 39465
        • Local Institution - 0224
      • Picayune, Mississippi, United States, 39466
        • Local Institution - 0060
      • Ridgeland, Mississippi, United States, 39157
        • Quinn Healthcare/SKYCRNG
    • Missouri
      • Saint Louis, Missouri, United States, 63123
        • Local Institution - 0116
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Local Institution - 0063
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Local Institution - 0222
      • Las Vegas, Nevada, United States, 89109
        • Local Institution
    • New Jersey
      • Linden, New Jersey, United States, 07036
        • Local Institution - 0334
    • New York
      • Brooklyn, New York, United States, 11229
        • Local Institution - 0249
      • Cooperstown, New York, United States, 13326
        • Local Institution - 0362
      • East Syracuse, New York, United States, 13057
        • Local Institution
      • Endwell, New York, United States, 13760
        • Local Institution - 0102
      • Niagara Falls, New York, United States, 14304
        • Local Institution - 0379
      • North Massapequa, New York, United States, 11758
        • Digiovanna Institute For Medical Education
    • North Carolina
      • Black Mountain, North Carolina, United States, 28711
        • Local Institution
      • Burlington, North Carolina, United States, 27215
        • Local Institution - 0328
      • Cary, North Carolina, United States, 27615
        • Local Institution - 0164
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte, LLC
      • Charlotte, North Carolina, United States, 28287
        • Local Institution - 0207
      • Durham, North Carolina, United States, 27701
        • Local Institution - 0006
      • Fayetteville, North Carolina, United States, 28304-3571
        • Local Institution
      • Franklinton, North Carolina, United States, 27525
        • Local Institution - 0268
      • Greensboro, North Carolina, United States, 27408
        • Local Institution - 0258
      • Hickory, North Carolina, United States, 28601
        • Local Institution - 0159
      • Matthews, North Carolina, United States, 28105
        • Local Institution - 0331
      • Raleigh, North Carolina, United States, 27609
        • Local Institution - 0230
      • Rocky Mount, North Carolina, United States, 27804
        • Local Institution - 0175
      • Salisbury, North Carolina, United States, 28144
        • Local Institution - 0253
      • Statesville, North Carolina, United States, 28625
        • Local Institution - 0153
      • Statesville, North Carolina, United States, 28625
        • Local Institution - 0182
      • Wilmington, North Carolina, United States, 28401-7307
        • Local Institution - 0235
      • Winston-Salem, North Carolina, United States, 27103-4109
        • Local Institution - 0167
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Sterling Research Group
      • Cincinnati, Ohio, United States, 45246
        • Local Institution - 0085
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0283
      • Columbus, Ohio, United States, 43213-3399
        • Local Institution - 0036
      • Dayton, Ohio, United States, 45406
        • Dayton Clinical Research
      • Dayton, Ohio, United States, 45419
        • Local Institution - 0212
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Local Institution - 0129
      • Pittsburgh, Pennsylvania, United States, 15208
        • Local Institution - 0272
      • Pittsburgh, Pennsylvania, United States, 15236-4604
        • Local Institution - 0236
      • Pittsburgh, Pennsylvania, United States, 15243
        • Local Institution - 0349
      • Uniontown, Pennsylvania, United States, 15401
        • Local Institution - 0347
      • Uniontown, Pennsylvania, United States, 15401
        • Local Institution - 0370
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Local Institution - 0240
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Local Institution - 0155
      • Knoxville, Tennessee, United States, 37912
        • Local Institution - 0234
      • Morristown, Tennessee, United States, 37813
        • Local Institution - 0324
      • Nashville, Tennessee, United States, 37212
        • Local Institution - 0309
    • Texas
      • Allen, Texas, United States, 75013
        • Wellness Clinical Research
      • Austin, Texas, United States, 78731
        • Local Institution - 0187
      • Austin, Texas, United States, 78745
        • Local Institution - 0243
      • Dallas, Texas, United States, 75240
        • HRMD Research
      • Denton, Texas, United States, 76210
        • Local Institution - 0242
      • Edinburg, Texas, United States, 78539
        • Invesclinic.U.S,LLC
      • Friendswood, Texas, United States, 77546
        • Local Institution - 0141
      • Georgetown, Texas, United States, 78628
        • Local Institution - 0354
      • Houston, Texas, United States, 77070
        • Local Institution - 0011
      • Houston, Texas, United States, 77095
        • Local Institution - 0343
      • Hurst, Texas, United States, 76054-3351
        • Local Institution - 0016
      • Laredo, Texas, United States, 78041
        • Local Institution - 0151
      • Mesquite, Texas, United States, 75149
        • Local Institution - 0170
      • Pearland, Texas, United States, 77584-7401
        • Local Institution - 0101
      • Pflugerville, Texas, United States, 78660
        • Local Institution - 0223
      • Pharr, Texas, United States, 78577
        • Local Institution - 0303
      • Plano, Texas, United States, 75025
        • Local Institution - 0204
      • Plano, Texas, United States, 75093
        • Local Institution - 0067
      • San Antonio, Texas, United States, 78220-2531
        • SA Premiere Internal Medicine
      • San Antonio, Texas, United States, 78249
        • Local Institution - 0092
      • San Marcos, Texas, United States, 78666-7579
        • Local Institution - 0278
      • Sugar Land, Texas, United States, 77479
        • Local Institution - 0055
      • Sugar Land, Texas, United States, 77479
        • Local Institution - 0137
      • The Woodlands, Texas, United States, 77382
        • Local Institution - 0251
      • The Woodlands, Texas, United States, 77384
        • Local Institution - 0147
      • Tyler, Texas, United States, 75702
        • Local Institution - 0322
    • Utah
      • Bountiful, Utah, United States, 84010
        • Local Institution - 0150
    • Virginia
      • Appomattox, Virginia, United States, 24522
        • Local Institution - 0339
      • Burke, Virginia, United States, 22015
        • Local Institution - 0191
      • Forest, Virginia, United States, 24551
        • Local Institution - 0340
      • Suffolk, Virginia, United States, 23435
        • Local Institution - 0267
      • Winchester, Virginia, United States, 22601
        • Local Institution - 0096
      • Winchester, Virginia, United States, 22601
        • Local Institution - 0364
    • Washington
      • Everett, Washington, United States, 98208
        • Local Institution - 0086
      • Tacoma, Washington, United States, 98498
        • Local Institution - 0299
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Local Institution - 0337
      • La Crosse, Wisconsin, United States, 54601
        • Local Institution - 0335
      • Madison, Wisconsin, United States, 53715
        • Local Institution - 0288

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Zio®XT Monitor Arm
Other: Zio®XT Monitor
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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