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

This study is ongoing, but not recruiting participants.
Bristol-Myers Squibb
Daiichi Sankyo Inc.
Boehringer Ingelheim
Information provided by (Responsible Party):
Duke University Identifier:
First received: March 6, 2014
Last updated: May 3, 2017
Last verified: September 2016
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

Condition Intervention
Atrial Fibrillation
Other: Educational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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

  • 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 ]

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

Estimated Enrollment: 2374
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT02082548

INECO Neurosciencias Orono
Rosario, Santa Fe, Argentina
Federal University of Sao Paulo
Sao Paulo, Brazil
Peking University First Hospital
Beijing, China
St Johns Medical College
Bangalore, India
University of Medicina and Pharmacy Carol Davila
Bucharest, Romania
Sponsors and Collaborators
Duke University
Bristol-Myers Squibb
Daiichi Sankyo Inc.
Boehringer Ingelheim
Principal Investigator: Christopher B Granger, MD Duke Clinical Research Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT02082548     History of Changes
Other Study ID Numbers: Pro00049709
Study First Received: March 6, 2014
Last Updated: May 3, 2017

Keywords provided by Duke University:
atrial fibrillation
educational intervention

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 25, 2017