This trial is active, not recruiting.

Condition atrial fibrillation
Treatment educational intervention
Sponsor Duke University
Collaborator Bristol-Myers Squibb
Start date June 2014
End date January 2017
Trial size 2374 participants
Trial identifier NCT02082548, Pro00049709


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
educational intervention arm
educational intervention
This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country
(No Intervention)
Standard of care

Primary Outcomes

Change in proportion of patients taking oral anticoagulants
time frame: 1 year

Secondary Outcomes

Change in proportion of patients able to continue anticoagulation
time frame: 1 year
Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation
time frame: 1 year
Death, total
time frame: 1 year
Stroke, hemorrhagic and non-hemorrhagic
time frame: 1 year
Major and non-major clinically relevant bleeding
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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 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)

Additional Information

Official title An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.
Principal investigator Christopher B Granger, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Duke University.