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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082548
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
Bristol-Myers Squibb
Daiichi Sankyo, Inc.
Boehringer Ingelheim
Bayer
Information provided by (Responsible Party):
Duke University

Study Description
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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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Educational Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.
Study Start Date : June 2014
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : May 9, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082548


Locations
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Argentina
INECO Neurosciencias Orono
Rosario, Santa Fe, Argentina
Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil
China
Peking University First Hospital
Beijing, China
India
St Johns Medical College
Bangalore, India
Romania
University of Medicina and Pharmacy Carol Davila
Bucharest, Romania
Sponsors and Collaborators
Duke University
Bristol-Myers Squibb
Daiichi Sankyo, Inc.
Boehringer Ingelheim
Bayer
Investigators
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Principal Investigator: Christopher B Granger, MD Duke Clinical Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02082548    
Other Study ID Numbers: Pro00049709
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Keywords provided by Duke University:
atrial fibrillation
anticoagulation
education
educational intervention
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes