Pleotropic Effect of New Oral Anticoagulants

Kyung Hee University

Status and phase: Unknown; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: dabigatran; Drug: Warfarin; Drug: ribaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02544932

PREFER-AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

dabigatran 110mg or 150mg

Experimental group

Description:

After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)

Treatment:

Drug: dabigatran

ribaroxaban 20mg

Experimental group

Description:

After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)

Treatment:

Drug: ribaroxaban

warfarin

Active Comparator group

Description:

After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)

Treatment:

Drug: Warfarin