A Phase 3 interventional study of dabigatran and ribaroxaban in Atrial Fibrillation, sponsored by Kyunghee University Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-09.
Sponsored by Kyunghee University Medical Center · Phase 3, Interventional, and Treatment
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 55 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Kyunghee University Medical Center is the lead sponsor of 62 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)
Drug: dabigatran
After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)
Drug: ribaroxaban
After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)
Drug: Warfarin
After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
Also known as: pradaxa
After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
Also known as: xarelto
After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
The changes in reactive hyperemia index (RHI)
Time frame: 12months
right and left maximum IMT of the common carotid artery (CCA)
Time frame: 24months
right and left mean IMT of the common carotid artery (CCA)
Time frame: 24months
adverse events
Time frame: 24months
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Kyunghee University Medical Center