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)

• ClinicalTrials.gov Identifier: NCT04126486
• Recruitment Status: Active, not recruiting
• First Posted: October 15, 2019
• Last Update Posted: November 18, 2022
• Sponsor: Bristol-Myers Squibb
• Collaborator: Pfizer
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: October 11, 2019
• First Posted Date: October 15, 2019
• Last Update Posted Date: November 18, 2022
• Actual Study Start Date: December 17, 2019
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Atrial Fibrillation
• Atrial Flutter

Intervention

Other: Zio®XT Monitor

A Zio® XT monitor will be affixed to the participant's chest

Study Arms

• Zio®XT Monitor Arm
  Intervention: Other: Zio®XT Monitor
• No Intervention: Usual Care Arm

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 8, 2022): 11931
• Original Estimated Enrollment (submitted: October 11, 2019): 52000
• Estimated Study Completion Date: June 30, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04126486
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Pfizer

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: November 2022