Clinical trial NCT02082548: Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation
Official title: An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
anticoagulation
education
educational intervention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Daiichi Sankyo
name: Boehringer Ingelheim
name: Bayer
First posted: 2014-03-10
Enrollment: 2374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Change in proportion of patients taking oral anticoagulants
timeFrame: 1 year
Secondary outcomes:
measure: Change in proportion of patients able to continue anticoagulation
timeFrame: 1 year
measure: Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation
timeFrame: 1 year
measure: Death, total
timeFrame: 1 year
measure: Stroke, hemorrhagic and non-hemorrhagic
timeFrame: 1 year
measure: Major and non-major clinically relevant bleeding
timeFrame: 1 year
Other outcomes:
measure: Systemic Embolism
timeFrame: 1 year
measure: Transient Ischemic Attack
timeFrame: 1 year
measure: Hospitalizations for cardiovascular causes
timeFrame: 1 year
measure: Time in therapeutic range for patients on vitamin K antagonists (VKA)
timeFrame: 1 year
Locations:
city: Rosario
country: Argentina
facility: INECO Neurosciencias Orono
state: Santa Fe
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
city: Beijing
country: China
facility: Peking University First Hospital
city: Bangalore
country: India
facility: St Johns Medical College
city: Bucharest
country: Romania
facility: University of Medicina and Pharmacy Carol Davila
Study officials:
affiliation: Duke Clinical Research Institute
name: Christopher B Granger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.