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

Atrial Fibrillation Clinical Trial

— IMPACT-AF  

Official title:

An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082548
• Other study ID #: Pro00049709
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: November 8, 2017
• Start date: June 2014
• Est. completion date: May 9, 2017

Study information

• Verified date: November 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2374
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Argentina	INECO Neurosciencias Orono	Rosario	Santa Fe
Brazil	Federal University of Sao Paulo	Sao Paulo
China	Peking University First Hospital	Beijing
India	St Johns Medical College	Bangalore
Romania	University of Medicina and Pharmacy Carol Davila	Bucharest

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

Argentina,  Brazil,  China,  India,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systemic Embolism		1 year
Other	Transient Ischemic Attack		1 year
Other	Hospitalizations for cardiovascular causes		1 year
Other	Time in therapeutic range for patients on vitamin K antagonists (VKA)		1 year
Primary	Change in proportion of patients taking oral anticoagulants	Change in proportion of patients taking oral anticoagulants from baseline to one year	1 year
Secondary	Change in proportion of patients able to continue anticoagulation	Change in proportion of patients able to continue anticoagulation for one year	1 year
Secondary	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	1 year
Secondary	Death, total		1 year
Secondary	Stroke, hemorrhagic and non-hemorrhagic		1 year
Secondary	Major and non-major clinically relevant bleeding		1 year