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OpenTrials
Completed

NCT Number: NCT04126486

A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke

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).

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution - 0302, Birmingham, Alabama, United States

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About this study

This a prospective, randomized study in primary care practices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zio®XT Monitor

Other

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

Primary outcomes

  1. Incidence of all strokes leading to hospitalization

    Time frame: From 2.5 years to 5 years after study start

  2. Incidence of bleeding leading to hospitalization

    Time frame: From 2.5 years to 5 years after study start

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Pfizer

Registry information

Official study title

GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals

Acronym: GUARD-AF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2019
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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