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Trial record 1 of 1 for:    GUARD AF
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126486
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study will determine if detection of undiagnosed atrial fibrillation in people 70 years of age or older reduces stroke risk compared to usual care.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Other: AF Detection Intervention Phase 4

Detailed Description:
This a prospective, randomized study in primary care practices.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
AF Detection Intervention
A Zio® XT monitor will be affixed to the participant's chest
Other: AF Detection Intervention
Zio® XT monitor

No Intervention: Usual Care
No Zio® XT monitor



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women at least 70 years of age
  • 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) Claims Database and to access data from electronic health records (EHR)
  • Health insurance by Medicare Fee-for-service or Medicare Advantage

Exclusion Criteria:

  • Oral anticoagulation (OAC) for any indication at the time of enrollment
  • History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented the EHR problem list
  • Any bleeding requiring medical attention within 30 days prior to enrollment
  • Known history of chronic kidney disease, Stage 5 Estimated Glomerular Filtration Rate (eGFR) < 15 ml/min/1.73 m2)
  • Any condition the investigator considers a contraindication to OAC
  • Any condition the investigator considers will prevent compliance with study instructions
  • Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, cardiac resynchronization therapy, and implantable loop recorders)
  • History of allergy to adhesive
  • Prior use of a cardiac monitor

Other protocol-defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126486


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
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United States, Florida
Local Institution Not yet recruiting
Hialeah, Florida, United States, 33012
Contact: Site 0145         
CHR Studies Recruiting
Miami, Florida, United States, 33144
Contact: Jose Garcia, Site 0025         
Block Nation Chase & Smolen Recruiting
Oviedo, Florida, United States, 32765-4515
Contact: Bradley Block, Site 0058         
JSV Clinical Research Study Inc Recruiting
Tampa, Florida, United States, 33613
Contact: Orlando Portal, Site 0028         
United States, Mississippi
Phillips Medical Services PLLC Recruiting
Jackson, Mississippi, United States, 39209
Contact: Andrea Phillips, Site 0089         
Northlake Cardiology Association Recruiting
Picayune, Mississippi, United States, 39466
Contact: Robert Lopez, Site 0060         
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04126486    
Other Study ID Numbers: CV185-749
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes