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Behavioral Intervention
Alert for Stroke (AF-ALERT3 Trial)
N/A
Waitlist Available
Led By Gregory Piazza, MD, MS
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
AF-ALERT3 Trial Summary
This trial aims to study the effectiveness of a computerized decision support system in increasing the prescription of anticoagulation for stroke prevention in atrial fibrillation. The study will involve multiple medical centers and
Who is the study for?
This trial is for patients with atrial fibrillation, a heart condition that increases the risk of stroke. It aims to improve how often doctors prescribe blood thinners to prevent strokes in these patients. The study will take place in community medical centers.Check my eligibility
What is being tested?
The trial is testing an alert-based computerized decision support system designed to help doctors follow guidelines on prescribing blood thinners more consistently. This system also assesses and manages bleeding risks associated with treatment.See study design
What are the potential side effects?
Since this trial tests a decision support tool rather than a medication, there are no direct side effects from the intervention itself. However, increased prescription of anticoagulants may lead to higher bleeding risks which the tool aims to manage.
AF-ALERT3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of major bleeding at 6 months from enrollment.
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
Secondary outcome measures
Frequency of a composite of major adverse cardiovascular events, defined as cerebrovascular accident, systemic embolism, any MI, symptomatic VTE, or all-cause mortality at 6 months from enrollment
Frequency of failure to prescribe anticoagulation because of perceived risk of bleeding in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation at the time of study enrollment and are assigned to the alert group
Other outcome measures
Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months.
Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported
AF-ALERT3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AlertExperimental Treatment1 Intervention
For Alert cluster sites, an on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the provider that his or her patient is at risk for stroke due to AF, and that there is no order for anticoagulation. Clinicians who receive the computer alert will have three options: 1) access an order template of United States (US) Food and Drug Administration (FDA)-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence-based clinical practice guidelines to learn more about stroke prevention in AF, or 3) continue with order entry after providing an explanation for why anticoagulation was not prescribed.
Group II: No AlertActive Control1 Intervention
For No Alert cluster sites, no computerized alert notification will be issued to providers.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,468,448 Total Patients Enrolled
16 Trials studying Stroke
1,165,998 Patients Enrolled for Stroke
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
305,490 Total Patients Enrolled
3 Trials studying Stroke
16,973 Patients Enrolled for Stroke
Gregory Piazza, MD, MSPrincipal InvestigatorBrigham and Women's Hospital
5 Previous Clinical Trials
10,870 Total Patients Enrolled
1 Trials studying Stroke
10,000 Patients Enrolled for Stroke
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted for enrollment in this ongoing research study?
"As per clinicaltrials.gov, this particular medical study is not currently seeking participants. The trial listing was first made available on July 1st, 2024 and last revised on April 2nd, 2024. Although inactive at the moment, there are a total of 1559 other ongoing trials actively seeking participants."
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