Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation
Overview
- Phase
- Phase 3
- Intervention
- dabigatran
- Conditions
- Atrial Fibrillation
- Sponsor
- Kyunghee University Medical Center
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- The changes in reactive hyperemia index (RHI)
- Last Updated
- 10 years ago
Overview
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.
Investigators
Weon Kim
professor
Kyunghee University Medical Center
Eligibility Criteria
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
Arms & Interventions
dabigatran 110mg or 150mg
After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)
Intervention: dabigatran
ribaroxaban 20mg
After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)
Intervention: ribaroxaban
warfarin
After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)
Intervention: Warfarin
Outcomes
Primary Outcomes
The changes in reactive hyperemia index (RHI)
Time Frame: 12months
Secondary Outcomes
- right and left mean IMT of the common carotid artery (CCA)(24months)
- right and left maximum IMT of the common carotid artery (CCA)(24months)
- adverse events(24months)