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

An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02082548

Acronym

IMPACT-AF

Enrollment

2374

Registered

2014-03-10

Start date

2014-06-30

Completion date

2017-05-09

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, anticoagulation, education, educational intervention

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

Interventions

OTHEREducational Intervention

This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)) * 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)

Design outcomes

Primary

Measure	Time frame	Description
Change in proportion of patients taking oral anticoagulants	1 year	Change in proportion of patients taking oral anticoagulants from baseline to one year

Secondary

Measure	Time frame	Description
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
Change in proportion of patients able to continue anticoagulation	1 year	Change in proportion of patients able to continue anticoagulation for one year
Death, total	1 year	—
Stroke, hemorrhagic and non-hemorrhagic	1 year	—
Major and non-major clinically relevant bleeding	1 year	—

Other

Measure	Time frame
Hospitalizations for cardiovascular causes	1 year
Time in therapeutic range for patients on vitamin K antagonists (VKA)	1 year
Transient Ischemic Attack	1 year
Systemic Embolism	1 year

Countries

Argentina, Brazil, China, India, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026