Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

Yokohama City University Medical Center200 enrolled

Overview

The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.

Previous study showed that administration of rivaroxaban reduced expression of proinflammatory mediators in apolipoprotein E-deficient mice. However, it is unknown whether the anti-inflammatory markers are decreased in patients with atrial fibrillation receiving novel oral anticoagulants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Atrial Fibrillation

Interventions

RivaroxabanDRUG

Patients are assigned to receive rivaroxaban 15mg once daily for 12 months. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.

DabigatranDRUG

Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * non-valvular atrial fibrillation * a CHADS2-VASc score of 1 or more Exclusion Criteria: * contraindication for rivaroxaban or dabigatran * stroke or systemic embolism, acute coronary syndromes or peripheral artery disease within 6 months before enrollment * acute heart failure * severe chronic renal failure (creatinine clearance \< 30mL/min.) * receiving dual antiplatelet therapy * patients with a body weight of 50kg or less * uncontrolled hypertension * active malignancy, collagen disease, or infectious disease * patients undergoing surgery within 6 months before enrollment * patients who are planned to undergoing catheter ablation for atrial fibrillation * patients who are not allowed to participate in the trial by judgement of the treating physician

Locations (16)

Ashigara Kami Hospital

Ashigaura, Kanagawa, Japan

RECRUITING

Chigasaki Municipal Hospital

Outcomes

Primary Outcomes

median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, and interleukin-18) between at baseline and 12 months later in each treatment group

Time frame: 12 months

Secondary Outcomes

change over time of above inflammatory markers during 12 months follow-up period (at baseline, 1 month, 3 months, 6 months, and 12 months later) in each treatment group

Time frame: 12 months

Central Contacts

Kengo Tsukahara, MD

CONTACT

81-45-261-5656 k-tsuka@urahp.yokohama-cu.ac.jp

Data from ClinicalTrials.gov

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