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

November 8, 2017 updated by: Duke University

An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • INECO Neurosciencias Orono
  • Brazil
      • Sao Paulo, Brazil
        • Federal University of São Paulo
  • China
      • Beijing, China
        • Peking University First Hospital
  • India
      • Bangalore, India
        • St Johns Medical College
  • Romania
      • Bucharest, Romania
        • University of Medicina and Pharmacy Carol Davila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
educational intervention arm
Other: 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: control
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
Death, total
Time Frame: 1 year
1 year
Stroke, hemorrhagic and non-hemorrhagic
Time Frame: 1 year
1 year
Major and non-major clinically relevant bleeding
Time Frame: 1 year
1 year

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Bristol-Myers Squibb
Bayer
Boehringer Ingelheim
Daiichi Sankyo, Inc.

Investigators

  • Principal Investigator: Christopher B Granger, MD, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 9, 2017

Study Completion (Actual)

May 9, 2017

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00049709

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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