Pleotropic Effect of New Oral Anticoagulants

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02544932
• Other study ID #: PREFER-AF
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 7, 2015
• Last updated: September 7, 2015
• Start date: October 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2015
• Source: Kyunghee University Medical Center
• Contact: Weon Kim, MD, PhD
• Phone: 82-2-958-8170
• Email: mylovekw[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in reactive hyperemia index (RHI)		12months	Yes
Secondary	right and left maximum IMT of the common carotid artery (CCA)		24months	Yes
Secondary	right and left mean IMT of the common carotid artery (CCA)		24months	Yes
Secondary	adverse events		24months	Yes