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Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter (AF-ALERT)

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ClinicalTrials.gov Identifier: NCT02339493
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Other: Computer Electronic Alert Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Alert-Based Computerized Decision Support for Stroke Prevention in High-Risk Hospitalized Patients With Atrial Fibrillation: A Randomized, Controlled Trial (AF-ALERT)
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alert Group
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.
Other: Computer Electronic Alert
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.

No Intervention: Control Group
If the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Frequency of composite of major adverse cardiovascular events at 90 days [ Time Frame: 90 days ]
    Defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment

  2. Frequency of stroke or transient ischemic attack (TIA) at 90 days [ Time Frame: 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.

  3. Frequency of acute myocardial infarction at 90 days [ Time Frame: 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.

  4. Frequency of all cause mortality at 90 days [ Time Frame: 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.

  5. Frequency of major bleeding or clinically relevant non-major bleeding at 90 days [ Time Frame: 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.

  6. Frequency of systemic embolism at 90 days [ Time Frame: 90 days ]
    Systemic embolism was defined as sudden loss of perfusion of a limb or extracranial organ



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339493


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Daiichi Sankyo, Inc.
Investigators
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Principal Investigator: Samuel Z Goldhaber, MD Brigham and Women's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samuel Z.Goldhaber, MD, Director, Thrombosis Research Group, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02339493    
Other Study ID Numbers: 2014P002317
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes