Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

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

Detailed Description
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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.

Official Title
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Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study-

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban
* Drug: Dabigatran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rivaroxaban<br>Patients are assigned to receive rivaroxaban 15mg once daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily. | Drug: Rivaroxaban<br>* 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.<br>* Other names: Xarelto;|
| Active Comparator: dabigatran<br>Patients are assigned to receive dabigatran 150mg twice daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients at a high risk of bleeding receive dabigatran 110mg twice daily. | Drug: Dabigatran<br>* Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.<br>* Other names: Pradaxa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, anticoagulation, inflammation