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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126486
Recruitment Status : Active, not recruiting
First Posted : October 15, 2019
Last Update Posted : November 18, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 11, 2019
First Posted Date  ICMJE October 15, 2019
Last Update Posted Date November 18, 2022
Actual Study Start Date  ICMJE December 17, 2019
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2022)
  • Incidence of all strokes leading to hospitalization [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • Incidence of all strokes [ Time Frame: 24 months ]
    Incidence of all strokes, ischemic and hemorrhagic, defined by International Classification of Disease (ICD) codes identified in the Center for Medicare & Medicaid Services (CMS) Medicare Claims Database
  • Incidence of bleeding leading to hospitalization [ Time Frame: 24 months ]
    Incidence of bleeding leading to hospitalization defined by International Classification of Disease (ICD) codes identified in the Center for Medicare & Medicaid Services (CMS) Medicare Claims Database
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
Number of prescriptions for oral anticoagulants for all participants [ Time Frame: 24 months ]
Claims for oral anticoagulants identified in Center for Medicare & Medicaid Services (CMS) Medicare Claims Database
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Flutter
Intervention  ICMJE Other: Zio®XT Monitor
A Zio® XT monitor will be affixed to the participant's chest
Study Arms  ICMJE
  • Zio®XT Monitor Arm
    Intervention: Other: Zio®XT Monitor
  • No Intervention: Usual Care Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 8, 2022)
11931
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2019)
52000
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04126486
Other Study ID Numbers  ICMJE CV185-749
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP