Pleotropic Effect of New Oral Anticoagulants
- Registration Number
- NCT02544932
- Lead Sponsor
- Kyunghee University Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 55
- CHA2DS2-VASc score above 2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ribaroxaban 20mg ribaroxaban After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily) dabigatran 110mg or 150mg dabigatran After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day) warfarin Warfarin After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)
- Primary Outcome Measures
Name Time Method The changes in reactive hyperemia index (RHI) 12months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Kyung Hee University
🇰🇷Seoul, Korea, Republic of