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Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation (IMPACT-AF)

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Duke University

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Other: Educational Intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02082548
Pro00049709

Details and patient eligibility

About

To determine whether a comprehensive evaluation and customized multilevel educational interventions will increase the rate of use of oral anticoagulants and the adherence and persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be differences in the use of oral anticoagulants and the persistence in patients between the control and interventional group. There will be a greater change in the use of oral anticoagulants over one year in the cohort in the intervention sites than the control sites. This will be due to two factors: greater initiation of oral anticoagulants among patients not treated at baseline and greater persistence of treatment for those on treatment at baseline

Enrollment

2,374 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Patients over the age of 18 with paroxysmal, persistent or permanent atrial fibrillation who have a 12-lead ECG showing atrial fibrillation and/or more than one rhythm strip showing atrial fibrillation at least 2 weeks apart, not due to a reversible cause (like post-CABG))
    1. At least one of the traditional CHADS2 risk factors or at least two CHA2DS2 VASc risk factors

Exclusion criteria

  • Mechanical prosthetic valve
  • Clinically unstable at the time of enrollment (ie, with ongoing shock)
  • Terminal illness and/or comfort care
  • Unable to provide consent (e.g. severe cognitive impairment)
  • Patients unable to have one year of follow-up for any reason
  • Clear and absolute contraindication to oral anticoagulation (for example, active bleeding or recent life-threatening bleeding such as ICH)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2,374 participants in 2 patient groups

Intervention
Experimental group
Description:
educational intervention arm
Treatment:
Other: Educational Intervention
control
No Intervention group
Description:
Standard of care

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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