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
  Purpose

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: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: June 2014
Estimated Primary Completion Date: December 2016 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082548

Locations
Argentina
INECO Neurosciencias Orono Not yet recruiting
Rosario, Santa Fe, Argentina
Contact: Meena Rao, MD, MPH    919-668-8936      
Principal Investigator: Maria Cecilia Bahit, MD         
Brazil
Federal University of Sao Paulo Not yet recruiting
Sao Paulo, Brazil
Contact: Meena Rao, MD MPH    9196688936      
Principal Investigator: Renato D Lopes, MD, MHS, PhD         
China
Peking University First Hospital Not yet recruiting
Beijing, China
Contact: Meena Rao, MD, MPH    919-668-8936      
Principal Investigator: Huo Yong, MD         
India
St Johns Medical College Not yet recruiting
Bangalore, India
Contact: Meena Rao, MD, MPH    919-668-8936      
Principal Investigator: Denis Xavier, MD, MSc         
Romania
University of Medicina and Pharmacy Carol Davila Recruiting
Bucharest, Romania
Contact: Meena Rao, MD    9196688936      
Principal Investigator: Dragos Vinereanu, MD, PhD         
Sponsors and Collaborators
Duke University
Bristol-Myers Squibb
Daiichi Sankyo Inc.
Boehringer Ingelheim
Bayer
Investigators
Principal Investigator: Christopher B Granger, MD Duke Clinical Research Institute
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02082548     History of Changes
Other Study ID Numbers: Pro00049709
Study First Received: March 6, 2014
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board
Romania: Ethics Committee
Argentina: Human Research Bioethics Committee
Brazil: National Committee of Ethics in Research
India: Indian Council of Medical Research
India: Institutional Review Board

Keywords provided by Duke University:
atrial fibrillation
anticoagulation
education
educational intervention

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014