Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Educational Intervention

• Registration Number: NCT02082548
• Lead Sponsor: Duke University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-10
• Study Start: 2014-06
• Primary Completion: 2017-05-09
• Study Completion: 2017-05-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2374

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))
• 2. At least one of the traditional CHADS2 risk factors or at least two CHA2DS2 VASc risk factors

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Educational Intervention	educational intervention arm

Primary Outcome Measures

Name	Time	Method
Change in proportion of patients taking oral anticoagulants	1 year	Change in proportion of patients taking oral anticoagulants from baseline to one year

Secondary Outcome Measures

Name	Time	Method
Death, total	1 year
Major and non-major clinically relevant bleeding	1 year
Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation	1 year	Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation at one year
Stroke, hemorrhagic and non-hemorrhagic	1 year
Change in proportion of patients able to continue anticoagulation	1 year	Change in proportion of patients able to continue anticoagulation for one year

Trial Locations

Locations (5)

Peking University First Hospital; 🇨🇳 Beijing, China

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil

University of Medicina and Pharmacy Carol Davila; 🇷🇴 Bucharest, Romania

St Johns Medical College; 🇮🇳 Bangalore, India

INECO Neurosciencias Orono; 🇦🇷 Rosario, Santa Fe, Argentina