Atrial FibrillationAF-ALERTNCT02339493
Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter
A study testing Computer Electronic Alert in people with Atrial Fibrillation and Stroke, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Computer Electronic Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-risk patients ≥ 21 years old with paroxysmal, persistent, or permanent nonvalvular AF or atrial flutter (CHA2DS2VASc score ≥ 1) who are not prescribed anticoagulant therapy for stroke prevention and are hospitalized at BWH will be eligible for randomization.
Who cannot join
- <21 years old
- no diagnosis of AF or atrial flutter
- not hospitalized at BWH
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Alert-Based Computerized Decision Support for Stroke Prevention in High-Risk Hospitalized Patients With Atrial Fibrillation: A Randomized, Controlled Trial (AF-ALERT)
Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial.
Read the detailed description
Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial. The investigators have the following specific aims:
Aim #1 (Primary Efficacy Endpoint)- To assess whether an alert-based computerized decision support strategy increases prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Hypothesis #1- An alert-based computer decision support (CDS) strategy will increase prescription of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Aim #2 (Secondary Efficacy Endpoint)- To determine the potential impact of an alert-based computerized decision support strategy on the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.
Hypothesis #2- This study will provide proof-of-concept data, including event rates, from which to design a larger randomized control trial to assess whether an alert-based CDS strategy will reduce the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Computer Electronic Alert
- 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.
Computer Electronic AlertOther
A computer program that will issue an on-screen electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. The alert will provide options for anticoagulation for stroke prevention in AF as well as additional information in the form of suggested reading.
| Study group | Role | What they receive |
|---|---|---|
| Alert Group | Experimental | If the patient is randomized to the alert group, their ordering provider will receive a computer electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. Receives: Other: Computer Electronic Alert |
| Control Group | No intervention | If the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Defined as prescription of therapeutic dose anticoagulation
Measured: 90 days
Secondary outcomes (6)
Frequency of composite of major adverse cardiovascular events at 90 days
Defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment
Measured: 90 days
Frequency of stroke or transient ischemic attack (TIA) at 90 days
An acute stroke was defined as a new, focal neurologic deficit of sudden onset, lasting at least 24 hours, not due to a readily identifiable nonvascular cause (e.g., brain tumor, trauma), as confirmed by a neurologist. All strokes required confirmation by imaging or autopsy. TIA was defined as a transient episode of neurologic dysfunction caused by suspected focal cerebral, spinal cord, or retinal ischemia without evidence of acute infarction and confirmed by a neurologist.
Measured: 90 days
Frequency of acute myocardial infarction at 90 days
Acute MI was defined as the detection of a rise and/or fall of cardiac biomarkers (cardiac troponin T), with at least one value being elevated above the 99th percentile upper reference limit and with at least one of the following: 1) symptoms of myocardial ischemia; 2) new (or presumably new) significant ST-segment/T-wave changes or left bundle branch block; 3) development of pathological Q waves on ECG; 4) new loss of viable myocardium or regional wall motion abnormality by imaging; or 5) identification of intracoronary thrombus by angiography or autopsy.
Measured: 90 days
Frequency of all cause mortality at 90 days
All-cause mortality was determined by review of the EHR. Causes of death were classified as stroke, myocardial infarction, pulmonary embolism, other cardiovascular cause, bleeding, cancer, or non-cardiovascular and non-cancer.
Measured: 90 days
Frequency of major bleeding or clinically relevant non-major bleeding at 90 days
Defined by the International Society on Thrombosis and Haemostasis [ISTH] bleeding classification system) at 90 days from enrollment.14 Using the ISTH classification, bleeding was defined as major if it was overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, required the transfusion of 2 or more units of blood, occurred into a critical site, or contributed to death. Clinically relevant non-major bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug.
Measured: 90 days
Frequency of systemic embolism at 90 days
Systemic embolism was defined as sudden loss of perfusion of a limb or extracranial organ
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startMay 2016
- Primary completionFeb 2018
- Study completionSep 2018
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo
- Responsible party
- Principal investigator, Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
- Investigators
- Samuel Z Goldhaber, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339493
- Sponsor's protocol ID
- 2014P002317
- Acronym
- AF-ALERT
- Status last verified
- Oct 2018
- First submitted
- 6 Jan 2015
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Piazza G, Hurwitz S, Carroll B, Goldhaber SZ. Patients with perceived high-bleeding risk and computerized decision support for stroke prevention in atrial fibrillation: an AF-ALERT substudy : Piazza: outcomes of high-bleeding risk AF patients. J Thromb Thrombolysis. 2021 Jul;52(1):281-290. doi: 10.1007/s11239-020-02296-0. Epub 2020 Sep 30.
PubMed 33000390Piazza 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 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alert-Based Computerized Decision Support for Stroke Prevention in High-Risk Hospitalized Patients With Atrial Fibrillation: A Randomized, Controlled Trial (AF-ALERT)
- ClinicalTrials.gov ID
- NCT02339493
- Acronym / sponsor ID
- AF-ALERT / 2014P002317
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Daiichi Sankyo
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 15 Jan 2015 (estimated)
- 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. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial.
Detailed description
Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial. The investigators have the following specific aims:
Aim #1 (Primary Efficacy Endpoint)- To assess whether an alert-based computerized decision support strategy increases prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Hypothesis #1- An alert-based computer decision support (CDS) strategy will increase prescription of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Aim #2 (Secondary Efficacy Endpoint)- To determine the potential impact of an alert-based computerized decision support strategy on the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.
Hypothesis #2- This study will provide proof-of-concept data, including event rates, from which to design a larger randomized control trial to assess whether an alert-based CDS strategy will reduce the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alert Group | Experimental | Other: Computer Electronic AlertIf the patient is randomized to the alert group, their ordering provider will receive a computer electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. |
| Control Group | No intervention | –If the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- High-risk patients ≥ 21 years old with paroxysmal, persistent, or permanent nonvalvular AF or atrial flutter (CHA2DS2VASc score ≥ 1) who are not prescribed anticoagulant therapy for stroke prevention and are hospitalized at BWH will be eligible for randomization.
Key exclusion criteria (3 listed)
- <21 years old
- no diagnosis of AF or atrial flutter
- not hospitalized at BWH
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 |
|---|---|---|
| Computer Electronic AlertA computer program that will issue an on-screen electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. The alert will provide options for anticoagulation for stroke prevention in AF as well as additional information in the form of suggested reading. | Other | Alert Group |
Primary outcome
Frequency of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Time frame: 90 days
Defined as prescription of therapeutic dose anticoagulation
6 secondary outcomes
Frequency of composite of major adverse cardiovascular events at 90 days
Time frame: 90 days
Frequency of stroke or transient ischemic attack (TIA) at 90 days
Time frame: 90 days
Frequency of acute myocardial infarction at 90 days
Time frame: 90 days
Frequency of all cause mortality at 90 days
Time frame: 90 days
Frequency of major bleeding or clinically relevant non-major bleeding at 90 days
Time frame: 90 days
Frequency of systemic embolism at 90 days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Derived from this study: PubMed 33000390Piazza G, Hurwitz S, Carroll B, Goldhaber SZ. Patients with perceived high-bleeding risk and computerized decision support for stroke prevention in atrial fibrillation: an AF-ALERT substudy : Piazza: outcomes of high-bleeding risk AF patients. J Thromb Thrombolysis. 2021 Jul;52(1):281-290. doi: 10.1007/s11239-020-02296-0. Epub 2020 Sep 30.
- Derived from this study: 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: No
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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. This study is not recruiting at the moment.
Samuel Z Goldhaber, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Electronic Alert in people with Atrial Fibrillation and Stroke, run by Brigham and Women's Hospital at 1 site 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 1 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: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment. (time frame: 90 days). 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 NCT02339493, 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 31 Oct 2018.