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

NCT02082548 | Completed DMC

• 1 other identifier: Pro00049709
• Study Type: interventional
• Target: 2,374
• Locations: 5 countries
• Sites: 5

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; anticoagulation; education; educational intervention

Outcome Measures

Primary Outcomes (1)

• Change in proportion of patients taking oral anticoagulants

  Change in proportion of patients taking oral anticoagulants from baseline to one year

  1 year

Secondary Outcomes (5)

• Change in proportion of patients able to continue anticoagulation

  1 year

• Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation

  1 year

• Death, total

  1 year

• Stroke, hemorrhagic and non-hemorrhagic

  1 year

• Major and non-major clinically relevant bleeding

  1 year

Other Outcomes (4)

• Systemic Embolism

  1 year

• Transient Ischemic Attack

  1 year

• Hospitalizations for cardiovascular causes

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

educational intervention arm

Other: Educational Intervention

control

NO INTERVENTION

Standard of care

Interventions

Educational Intervention OTHER

This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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))
• \. At least one of the traditional CHADS2 risk factors or at least two CHA2DS2 VASc risk factors

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Bristol-Myers Squibb: collaborator
• Daiichi Sankyo: collaborator
• Boehringer Ingelheim: collaborator
• Bayer: collaborator

Study Sites (5)

INECO Neurosciencias Orono

Rosario, Santa Fe Province, Argentina

Location

Federal University of Sao Paulo

São Paulo, Brazil

Location

Peking University First Hospital

Beijing, China

Location

St Johns Medical College

Bangalore, India

Location

University of Medicina and Pharmacy Carol Davila

Bucharest, Romania

Location

Related Publications (2)

• 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.

  PMID: 28859942 DERIVED

• 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.

  PMID: 27264227 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Christopher B Granger, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: June 1, 2014
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

AR (1); BR (1); IN (1); CN (1); RO (1)