Status:
COMPLETED
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Pfizer
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
70+ years
Phase:
PHASE4
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...
Detailed Description
This a prospective, randomized study in primary care practices.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
11931 Patients enrolled
Trial Details
Trial ID
NCT04126486
Start Date
December 17 2019
End Date
June 30 2023
Last Update
July 12 2023
Active Locations (176)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0302
Birmingham, Alabama, United States, 35209
2
Local Institution - 0360
Guntersville, Alabama, United States, 35976
3
Local Institution - 0158
Montgomery, Alabama, United States, 36106
4
Local Institution - 0109
Kingman, Arizona, United States, 86409