Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran (RIVAL-AF)

Yokohama City University Medical Center

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Dabigatran; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02331602

Kimura5656

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

rivaroxaban

Active Comparator group

Description:

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.

Treatment:

Drug: Rivaroxaban

dabigatran

Active Comparator group

Description:

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.

Treatment:

Drug: Dabigatran