NCT02544932

Pleotropic Effect of New Oral Anticoagulants

Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	dabigatran	After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
DRUG	ribaroxaban	After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
DRUG	Warfarin	After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-09-09
• Last updated: 2015-09-09

Locations

1 site across 1 country: South Korea