Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Non-interventional

• Registration Number: NCT03313167
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-29
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-18
• Primary Completion: 2019-05-23
• Study Completion: 2019-05-23
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1316

Inclusion Criteria

• Age ≥ 65 and one or more of the following: hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease

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Exclusion Criteria

• Age < 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial Fibrillation-potential Patients	Non-interventional	individuals 65 years of age or older with moderate-to-high risk of stroke

Primary Outcome Measures

Name	Time	Method
number of subjects screened with AF not identified at Index Visit	Up to 4 weeks from Index Visit	number of subjects screened who have AF not identified at their Index Visit but subsequently found to have AF confirmed by 12-lead Electrocardiogram (ECG) during the extended monitoring period
number of subjects screened with AF identified at Index Visit	Up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period	Day 1 up to week 24
number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period	Index Visit up to week 24
number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period	Day 1 up to week 24
number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy	24 week follow up period
number of subjects with AF identified at their Index Visit who are prescribed guideline recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up period	At week 24
number of subjects with PAF identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up	At week 24
number of subjects with ECG-confirmed AF detected by the Omron BP device	Day 1 to Day 14	number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period
number of subjects with ECG-confirmed AF detected by MB or HCG-801	Day 14 to Day 28	number of subjects with ECG-confirmed AF detected by MyBeat (MB) or Omron HeartScan 801 (HCG-801) during the extended monitoring period
number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy	Day 1 to Day 28
number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period	Index Visit up to week 24

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Itabashi-ku, Tokyo, Japan