Computerized Decision Support to Prevent Stroke in Atrial Fibrillation

This study is looking at a new way to help prevent strokes in people with atrial fibrillation (AF), a condition where the heart beats irregularly. It's testing an "Alert-based computerized decision support" system. This system will show an on-screen alert to doctors during appointments if their patient with AF is at high risk for stroke but isn't taking blood thinners (anticoagulation) to prevent it. The goal is to see if these alerts help more high-risk AF patients get a prescription for anticoagulation within 90 days. Researchers will also track how often major bleeding occurs within 6 months. You might be able to join if you are 18 or older, have AF, and a specific risk score (CHA2DS2VASc score of 2 or more for males, 3 or more for females), and are not currently taking blood thinners. The study plans to include about 2500 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 2500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow up on anticoagulation prescriptions at 90 days and major bleeding at 6 months.

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NCT06355986

Computerized Decision Support to Prevent Stroke in Atrial Fibrillation

Not Yet Recruiting
NAAges 18+InterventionalPrevention
Brigham and Women's Hospital
~2,500 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:Alert-based computerized decision support

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment
Measured over 90 days
+1 more outcome measured
Atrial Fibrillation
Stroke
2 sites across 2 states
Kentucky1
Massachusetts1
  • Gregory Piazza, MD, MS · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

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Eligibility criteria

Inclusion

Male and Female
Age ≥ 18 years
Problem list entry of atrial fibrillation or atrial flutter
CHA2DS2VASc score ≥ 2 for males
CHA2DS2VASc score ≥ 3 for females
No prescription for anticoagulant therapy

Exclusion

Active prescription for anticoagulant therapy
CHA2DS2VASc score \< 2 for males
CHA2DS2VASc score ≤ 2 for females
  • Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment90 days

    The primary efficacy outcome will be determined by review of the Electronic Health Record (EHR) medication documentation for prescription of anticoagulation by 90 days after enrollment. These data will be collected in the form of a BPA report and then confirmed by independent data abstractors.

  • Frequency of major bleeding at 6 months from enrollment.6 months

    Defined by the ISTH bleeding classification system. These data will be confirmed by independent data abstractors and then independently adjudicated by a blinded 3-physician expert Clinical Events Committee.