Pleotropic Effect of New Oral Anticoagulants

NCT ID: NCT02544932

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dabigatran 110mg or 150mg

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

Group Type EXPERIMENTAL

dabigatran

Intervention Type DRUG

After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months

ribaroxaban 20mg

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

Group Type EXPERIMENTAL

ribaroxaban

Intervention Type DRUG

After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.

warfarin

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

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.

Interventions

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dabigatran

After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months

Intervention Type DRUG

ribaroxaban

After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.

Intervention Type DRUG

Warfarin

After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.

Intervention Type DRUG

Other Intervention Names

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pradaxa xarelto

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Weon Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University Medical Center

Locations

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Kyung Hee University

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Weon Kim, MD, PhD

Role: CONTACT

82-2-958-8170

Jin-Bae Kim, MD, PhD

Role: CONTACT

82-2-958-8167

References

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Kim JB, Joung HJ, Lee JM, Woo JS, Kim WS, Kim KS, Lee KH, Kim W. Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial. Trials. 2016 Aug 24;17(1):422. doi: 10.1186/s13063-016-1541-8.

Reference Type DERIVED
PMID: 27558002 (View on PubMed)

Other Identifiers

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PREFER-AF

Identifier Type: -

Identifier Source: org_study_id

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