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Completed

NCT Number: NCT02082548

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INECO Neurosciencias Orono, Rosario, Santa Fe Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Educational Intervention

Other

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

Primary outcomes

  1. Change in proportion of patients taking oral anticoagulants

    Time frame: 1 year

    Change in proportion of patients taking oral anticoagulants from baseline to one year

Secondary outcomes

  1. Change in proportion of patients able to continue anticoagulation

    Time frame: 1 year

    Change in proportion of patients able to continue anticoagulation for one year

  2. Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation

    Time frame: 1 year

    Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation at one year

  3. Death, total

    Time frame: 1 year

  4. Stroke, hemorrhagic and non-hemorrhagic

    Time frame: 1 year

  5. Major and non-major clinically relevant bleeding

    Time frame: 1 year

Other outcomes

  1. Systemic Embolism

    Time frame: 1 year

  2. Transient Ischemic Attack

    Time frame: 1 year

  3. Hospitalizations for cardiovascular causes

    Time frame: 1 year

  4. Time in therapeutic range for patients on vitamin K antagonists (VKA)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Bayer
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Daiichi Sankyo

Registry information

Official study title

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

Acronym: IMPACT-AF

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2014
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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