Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter



Status:Completed
Conditions:Atrial Fibrillation, Atrial Fibrillation, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:21 - Any
Updated:11/2/2018
Start Date:May 2016
End Date:September 2018

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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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- <21 years old

- no diagnosis of AF or atrial flutter

- not hospitalized at BWH
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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mi
from
Boston, MA
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