Atrial Fibrillation
Conditions
Keywords
anticoagulant, atherosclerosis, endothelium
Brief summary
Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.
Detailed description
The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.
Interventions
DRUGdabigatran
After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
DRUGribaroxaban
After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
DRUGWarfarin
After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
Sponsors
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* CHA2DS2-VASc score above 2
Exclusion criteria
* severe peripheral arterial disease (greater than a Fontaine IIb category) * grade 4 or higher cerebral infarction on the Modified Rankin Scale * proven coronary artery disease by coronary angiogram * severe hepatic or renal dysfunction * uncontrolled congestive heart failure * uncontrolled hypertension or diabetes mellitus * hematologic disorders * allergy or hypersensitivity to the investigational drugs * pregnant or lactating women or women wishing to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in reactive hyperemia index (RHI) | 12months |
Secondary
| Measure | Time frame |
|---|---|
| right and left maximum IMT of the common carotid artery (CCA) | 24months |
| right and left mean IMT of the common carotid artery (CCA) | 24months |
| adverse events | 24months |
Countries
South Korea
Contacts
Primary ContactWeon Kim, MD, PhD
Backup ContactJin-Bae Kim, MD, PhD
Outcome results
None listed