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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Duke University
Sponsor:
Collaborators:
Bristol-Myers Squibb
Daiichi Sankyo Inc.
Boehringer Ingelheim
Bayer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02082548
First received: March 6, 2014
Last updated: June 9, 2014
Last verified: June 2014

March 6, 2014
June 9, 2014
June 2014
December 2016   (final data collection date for primary outcome measure)
Change in proportion of patients taking oral anticoagulants [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Stroke, hemorrhagic and non-hemorrhagic [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Major and non-major clinically relevant bleeding [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
  • Systemic Embolism [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attack [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Hospitalizations for cardiovascular causes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Time in therapeutic range for patients on vitamin K antagonists (VKA) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
Not Provided
December 2016   (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)
Both
18 Years and older
No
Argentina,   Brazil,   China,   India,   Romania
 
NCT02082548
Pro00049709
Yes
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
June 2014

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