Atrial Fibrillation Clinical Trial
— GUARD-AFOfficial title:
GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
| Verified date | July 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 11931 |
| Est. completion date | June 30, 2023 |
| Est. primary completion date | June 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 70 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0263 | Albany | Georgia |
| United States | Wellness Clinical Research | Allen | Texas |
| United States | Local Institution - 0338 | Ames | Iowa |
| United States | Local Institution - 0351 | Annapolis | Maryland |
| United States | Local Institution - 0339 | Appomattox | Virginia |
| United States | Local Institution - 0027 | Atlanta | Georgia |
| United States | Local Institution - 0187 | Austin | Texas |
| United States | Local Institution - 0243 | Austin | Texas |
| United States | Local Institution | Aventura | Florida |
| United States | Johns Hopkins | Baltimore | Maryland |
| United States | Belzoni Family Practice | Belzoni | Mississippi |
| United States | Local Institution - 0302 | Birmingham | Alabama |
| United States | Local Institution | Black Mountain | North Carolina |
| United States | Local Institution - 0051 | Boston | Massachusetts |
| United States | Local Institution - 0284 | Boston | Massachusetts |
| United States | Local Institution - 0150 | Bountiful | Utah |
| United States | Local Institution - 0143 | Boynton Beach | Florida |
| United States | Local Institution - 0155 | Bristol | Tennessee |
| United States | Local Institution - 0249 | Brooklyn | New York |
| United States | Local Institution - 0191 | Burke | Virginia |
| United States | Local Institution - 0328 | Burlington | North Carolina |
| United States | Hope Clinical Research | Canoga Park | California |
| United States | Local Institution - 0260 | Caro | Michigan |
| United States | Local Institution - 0164 | Cary | North Carolina |
| United States | Local Institution - 0207 | Charlotte | North Carolina |
| United States | PMG Research of Charlotte, LLC | Charlotte | North Carolina |
| United States | Local Institution - 0311 | Chicago | Illinois |
| United States | Local Institution - 0085 | Cincinnati | Ohio |
| United States | Sterling Research Group | Cincinnati | Ohio |
| United States | Local Institution - 0017 | Clearwater | Florida |
| United States | Local Institution - 0232 | Clearwater | Florida |
| United States | Local Institution - 0283 | Cleveland | Ohio |
| United States | Local Institution | Columbus | Georgia |
| United States | Local Institution - 0036 | Columbus | Ohio |
| United States | Local Institution - 0362 | Cooperstown | New York |
| United States | HRMD Research | Dallas | Texas |
| United States | Dayton Clinical Research | Dayton | Ohio |
| United States | Local Institution - 0212 | Dayton | Ohio |
| United States | Local Institution - 0062 | DeLand | Florida |
| United States | University Clinical Research-Deland LLC dba Accel Research Sites | DeLand | Florida |
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| United States | Vanguard Clinical Research, LLC | Fort Myers | Florida |
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| United States | Local Institution - 0141 | Friendswood | Texas |
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| United States | Local Institution - 0147 | The Woodlands | Texas |
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| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of all strokes leading to hospitalization | From 2.5 years to 5 years after study start | ||
| Primary | Incidence of bleeding leading to hospitalization | From 2.5 years to 5 years after study start |
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