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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02082548
First Posted: March 10, 2014
Last Update Posted: November 10, 2017
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.
Collaborators:
Bristol-Myers Squibb
Daiichi Sankyo, Inc.
Boehringer Ingelheim
Bayer
Information provided by (Responsible Party):
Duke University
March 6, 2014
March 10, 2014
November 10, 2017
June 2014
May 9, 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02082548 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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 ]
Same as current
 
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.
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
Other: Educational Intervention
This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country
  • Experimental: Intervention
    educational intervention arm
    Intervention: Other: Educational Intervention
  • No Intervention: control
    Standard of care
Rao MP, Ciobanu AO, Lopes RD, Fox KA, Xian Y, Pokorney SD, Al-Khalidi HR, Jiang J, Kamath DY, Berwanger O, Xavier D, Bahit CM, Tajer C, Vinereanu D, Huo Y, Granger CB. A clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AF): design and rationale. Am Heart J. 2016 Jun;176:107-13. doi: 10.1016/j.ahj.2016.03.011. Epub 2016 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2374
May 9, 2017
May 9, 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   China,   India,   Romania
 
 
NCT02082548
Pro00049709
Yes
Not Provided
Not Provided
Duke University
Duke University
  • Bristol-Myers Squibb
  • Daiichi Sankyo, Inc.
  • Boehringer Ingelheim
  • Bayer
Principal Investigator: Christopher B Granger, MD Duke Clinical Research Institute
Duke University
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP