Atrial FibrillationAF-ALERT3NCT06355986
Computerized Decision Support to Prevent Stroke in Atrial Fibrillation
A study testing Alert-based computerized decision support in people with Atrial Fibrillation and Stroke, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Alert-based computerized decision support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active prescription for anticoagulant therapy
- CHA2DS2VASc score < 2 for males
- CHA2DS2VASc score ≤ 2 for females
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mass General Brigham
Boston, Massachusetts, 02115
Gregory Piazza, MD, MS, 781-956-5525, gregorypiazza@hotmail.com
St. Elizabeth Health
Edgewood, Kentucky, 41017
Benjamin Peterson, MD, 617-987-1046, benjamin.peterson@stelizabeth.com
About this study
Official title: Community-Based, Cluster-Randomized Trial of Electronic Alert-Based Computerized Decision Support to Prevent Stroke in High-Risk Ambulatory Patients With Atrial Fibrillation (AF-ALERT3)
Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management.
Read the detailed description
Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the MGB health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Implementation science strategies, including computerized decision support (CDS), have been proposed as solutions to improve adherence to guideline recommendations. A previously conducted randomized controlled trial of alert-based CDS in 458 high-risk hospitalized patients with AF who were not being anticoagulated showed that the alert nearly tripled the proportion of hospitalized patients with AF and high-risk of stroke who were prescribed anticoagulation during the hospitalization, at discharge, and at 90 days compared with the control group. CDS in this trial was associated with an 88% reduction in the frequency of stroke or systemic embolic event and 87% reduction in the frequency of myocardial infarction (MI) at 90 days. A subsequent trial demonstrated that clinician-directed, alert-based CDS doubled prescription of antithrombotic therapy in high-risk ambulatory care patients with AF who were not prescribed anticoagulation at the time of randomization. A major lesson from the second trial was the importance that perceived bleeding risk played in the shared decision-making process between clinician and patient. These two trials demonstrated that bleeding risk is the predominant consideration when omitting anticoagulation or choosing to bypass a CDS alert. Clinicians often overestimate bleeding risk compared with objective bleeding risk scores (HAS-BLED).
Both prior trials were executed at a large tertiary-care center in Boston, Massachusetts. The feasibility and impact of an alert-based CDS strategy to improve stroke prevention in AF among ambulatory care patients in the community setting and outside of major tertiary-care centers remains to be determined. To address the feasibility and impact of a CDS strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, community-based, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Alert-based computerized decision support
- Keywords
- atrial fibrillation, stroke, prevention, computerized decision support, anticoagulation
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert-based computerized decision supportBehavioural
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Alert | Experimental | 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. Receives: Behavioral: Alert-based computerized decision support |
| No Alert | No intervention | For No Alert cluster sites, no computerized alert notification will be issued to providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 90 days
Frequency of major bleeding at 6 months from enrollment.
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.
Measured: 6 months
Secondary outcomes (2)
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
The frequency of this outcome will be compared with that from an earlier study as a historical cohort. This outcome will be determined by review of the EHR.
Measured: At 48 hours
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
The secondary efficacy outcome will be determined by review of the EHR medication documentation. These data will be confirmed by independent data abstractors and then independently adjudicated by a blinded 3-physician expert Clinical Events Committee.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start30 Dec 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2500-patient U.S. multicenter, community-based Quality Improvement Initiative in the form of a cluster-randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Principal investigator, Gregory Piazza, MD, MS, Brigham and Women's Hospital
- Investigators
- Gregory Piazza, MD, MS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355986
- Sponsor's protocol ID
- 39039039AFL4016
- Acronym
- AF-ALERT3
- Status last verified
- Feb 2026
- First submitted
- 27 Mar 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request
Publications
Piazza G, Hurwitz S, Campia U, Bikdeli B, Lou J, Khairani CD, Bejjani A, Snyder JE, Pfeferman M, Barns B, Rizzo S, Glezer A, Goldhaber SZ. Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2). Thromb Res. 2023 Jul;227:1-7. doi: 10.1016/j.thromres.2023.05.006. Epub 2023 May 11.
PubMed 37182298Piazza G, Hurwitz S, Galvin CE, Harrigan L, Baklla S, Hohlfelder B, Carroll B, Landman AB, Emani S, Goldhaber SZ. Alert-based computerized decision support for high-risk hospitalized patients with atrial fibrillation not prescribed anticoagulation: a randomized, controlled trial (AF-ALERT). Eur Heart J. 2020 Mar 7;41(10):1086-1096. doi: 10.1093/eurheartj/ehz385.
PubMed 31228189
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based, Cluster-Randomized Trial of Electronic Alert-Based Computerized Decision Support to Prevent Stroke in High-Risk Ambulatory Patients With Atrial Fibrillation (AF-ALERT3)
- ClinicalTrials.gov ID
- NCT06355986
- Acronym / sponsor ID
- AF-ALERT3 / 39039039AFL4016
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- atrial fibrillation, stroke, prevention, computerized decision support, anticoagulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management.
Detailed description
Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the MGB health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Implementation science strategies, including computerized decision support (CDS), have been proposed as solutions to improve adherence to guideline recommendations. A previously conducted randomized controlled trial of alert-based CDS in 458 high-risk hospitalized patients with AF who were not being anticoagulated showed that the alert nearly tripled the proportion of hospitalized patients with AF and high-risk of stroke who were prescribed anticoagulation during the hospitalization, at discharge, and at 90 days compared with the control group. CDS in this trial was associated with an 88% reduction in the frequency of stroke or systemic embolic event and 87% reduction in the frequency of myocardial infarction (MI) at 90 days. A subsequent trial demonstrated that clinician-directed, alert-based CDS doubled prescription of antithrombotic therapy in high-risk ambulatory care patients with AF who were not prescribed anticoagulation at the time of randomization. A major lesson from the second trial was the importance that perceived bleeding risk played in the shared decision-making process between clinician and patient. These two trials demonstrated that bleeding risk is the predominant consideration when omitting anticoagulation or choosing to bypass a CDS alert. Clinicians often overestimate bleeding risk compared with objective bleeding risk scores (HAS-BLED).
Both prior trials were executed at a large tertiary-care center in Boston, Massachusetts. The feasibility and impact of an alert-based CDS strategy to improve stroke prevention in AF among ambulatory care patients in the community setting and outside of major tertiary-care centers remains to be determined. To address the feasibility and impact of a CDS strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, community-based, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2500-patient U.S. multicenter, community-based Quality Improvement Initiative in the form of a cluster-randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Alert | Experimental | Behavioral: Alert-based computerized decision supportFor 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. |
| No Alert | No intervention | –For No Alert cluster sites, no computerized alert notification will be issued to providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Active prescription for anticoagulant therapy
- CHA2DS2VASc score < 2 for males
- CHA2DS2VASc score ≤ 2 for females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alert-based computerized decision supportAn 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 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. | Behavioural | Alert |
Primary outcome
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
Time frame: 90 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.
Time frame: 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.
2 secondary outcomes
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
Time frame: At 48 hours
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
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 37182298Piazza G, Hurwitz S, Campia U, Bikdeli B, Lou J, Khairani CD, Bejjani A, Snyder JE, Pfeferman M, Barns B, Rizzo S, Glezer A, Goldhaber SZ. Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2). Thromb Res. 2023 Jul;227:1-7. doi: 10.1016/j.thromres.2023.05.006. Epub 2023 May 11.
- Background: PubMed 31228189Piazza G, Hurwitz S, Galvin CE, Harrigan L, Baklla S, Hohlfelder B, Carroll B, Landman AB, Emani S, Goldhaber SZ. Alert-based computerized decision support for high-risk hospitalized patients with atrial fibrillation not prescribed anticoagulation: a randomized, controlled trial (AF-ALERT). Eur Heart J. 2020 Mar 7;41(10):1086-1096. doi: 10.1093/eurheartj/ehz385.
- Individual participant dataSharing planned: Yes. Upon reasonable request
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Piazza, MD, MS principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert-based computerized decision support in people with Atrial Fibrillation and Stroke, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Piazza, MD, MS (7819565525, gregorypiazza@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355986, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.