Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-12-31

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.

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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.

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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rivaroxaban

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.

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

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.

dabigatran

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.

Group Type ACTIVE_COMPARATOR

Dabigatran

Intervention Type DRUG

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

Interventions

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Rivaroxaban

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.

Intervention Type DRUG

Dabigatran

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

Intervention Type DRUG

Other Intervention Names

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Xarelto Pradaxa

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No