Newswires
GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
2019 OCT 28 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT04126486 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •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 |
| •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 |
|
| Current Secondary Outcome Measures | •Number of prescriptions for oral anticoagulants for all participants [ Time Frame: 24 months ] -- Claims for oral anticoagulants identified in |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT04126486 |
Descriptive Information
| Brief Title | 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 | GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals |
| 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. |
| Detailed Description | This a prospective, randomized study in primary care practices. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized |
| Intervention Model: Parallel Assignment | |
| Primary Purpose: Prevention | |
| Masking: None (Open Label) | |
| Condition | Atrial Fibrillation |
| Atrial Flutter | |
| Intervention | •Other: AF Detection Intervention |
| Zio® XT monitor | |
| Study Arms | •Other: AF Detection Intervention |
| A Zio® XT monitor will be affixed to the participant’s chest | |
| Interventions: | |
| ⚬Other: AF Detection Intervention |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 52000 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | 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 |
|
| •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 | |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 70 years and older |
| No | |
| Contacts | Primary contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,, please email:, [email protected] |
| Backup contact: First line of the email MUST contain NCT# and Site #., , | |
| Listed Location Countries | Not Provided |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT04126486 |
| Other Study ID Numbers | CV185-749 |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | Not Provided |
| Plan to Share Data (IPD) Description | Not Provided |
| Collaborators | Not Provided |
| Investigators | Study Director: |
| Information Provided By | |
| Verification Date |
(Our reports deliver fact-based news of research and discoveries from around the world.)
Two Sonoma County wineries damaged by Kincade fire in Alexander Valley
Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier
Advisor News
- Advisors must lead the policy risk conversation
- Gen X more anxious than baby boomers about retirement
- Taxing trend: How the OBBBA is breaking the standard deduction reliance
- Why advisors can’t afford to delay succession planning
- 6 in 10 Americans struggle with financial decisions
More Advisor NewsAnnuity News
- CT commissioner: 70% of policyholders covered in PHL liquidation plan
- ‘I get confused:’ Regulators ponder increasing illustration complexities
- Three ways the Corebridge/Equitable merger could shake up the annuity market
- Corebridge, Equitable merge to create potential new annuity sales king
- LIMRA: Final retail annuity sales total $464.1 billion in 2025
More Annuity NewsHealth/Employee Benefits News
- Select Board starts process to shift to new health insurance provider
- Advocates call for hearing about Geisinger-Risant insurance condition change request
- Tucson Speaks Out: April 5
- El Rio taps experienced leader to oversee transition from North Country HealthCare to Elk Ridge
- Red ink at Minnesota Blue Cross spells more Medicare Advantage troubles ahead
More Health/Employee Benefits NewsLife Insurance News
- WHAT THEY ARE SAYING: KATHLEEN COULOMBE JOINS ACU AS CHIEF ADVOCACY OFFICER
- A-CAP Appoints Kirk Cullimore as President of Sentinel Security Life
- Nationwide enters centennial year stronger than ever
- AM Best Affirms Credit Ratings of Mutual of Omaha Insurance Company and Its Subsidiaries
- AM Best Affirms Credit Ratings of CMB Wing Lung Insurance Company Limited
More Life Insurance News