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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, anticoagulation, education, educational intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • INECO Neurosciencias Orono
  • Federal University of Sao Paulo
  • Peking University First Hospital
  • St Johns Medical College
  • University of Medicina and Pharmacy Carol Davila

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control

Arm Description

educational intervention arm

Standard of care

Outcomes

Primary Outcome Measures

Change in proportion of patients taking oral anticoagulants
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
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
Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation at one year
Death, total
Stroke, hemorrhagic and non-hemorrhagic
Major and non-major clinically relevant bleeding

Full Information

First Posted
March 6, 2014
Last Updated
November 8, 2017
Sponsor
Duke University
Collaborators
Bristol-Myers Squibb, Daiichi Sankyo, Inc., Boehringer Ingelheim, Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02082548
Brief Title
Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation
Acronym
IMPACT-AF
Official Title
An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 9, 2017 (Actual)
Study Completion Date
May 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Bristol-Myers Squibb, Daiichi Sankyo, Inc., Boehringer Ingelheim, Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, anticoagulation, education, educational intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2374 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
educational intervention arm
Arm Title
control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Intervention Description
This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country
Primary Outcome Measure Information:
Title
Change in proportion of patients taking oral anticoagulants
Description
Change in proportion of patients taking oral anticoagulants from baseline to one year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in proportion of patients able to continue anticoagulation
Description
Change in proportion of patients able to continue anticoagulation for one year
Time Frame
1 year
Title
Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation
Description
Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation at one year
Time Frame
1 year
Title
Death, total
Time Frame
1 year
Title
Stroke, hemorrhagic and non-hemorrhagic
Time Frame
1 year
Title
Major and non-major clinically relevant bleeding
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Systemic Embolism
Time Frame
1 year
Title
Transient Ischemic Attack
Time Frame
1 year
Title
Hospitalizations for cardiovascular causes
Time Frame
1 year
Title
Time in therapeutic range for patients on vitamin K antagonists (VKA)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher B Granger, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
INECO Neurosciencias Orono
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
St Johns Medical College
City
Bangalore
Country
India
Facility Name
University of Medicina and Pharmacy Carol Davila
City
Bucharest
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
28859942
Citation
Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28.
Results Reference
derived
PubMed Identifier
27264227
Citation
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.
Results Reference
derived

Learn more about this trial

Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation

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