A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
NCT04126486
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
please email:
- 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)
- 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
Other protocol-defined inclusion/exclusion criteria could apply
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Descriptive Information | |||||||||
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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 |
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Intervention ICMJE | Other: Zio®XT Monitor
A Zio® XT monitor will be affixed to the participant's chest | ||||||||
Study Arms ICMJE |
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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 | Recruiting | ||||||||
Estimated Enrollment ICMJE | 52000 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 1, 2021 | ||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply | ||||||||
Sex/Gender ICMJE |
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Ages ICMJE | 70 Years and older (Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Bristol-Myers Squibb | ||||||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
| ||||||||
PRS Account | Bristol-Myers Squibb | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |