Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study

Not Applicable

• Conditions: non-valvular atrial fibrillation

• Registration Number: JPRN-UMIN000009553
• Lead Sponsor: Division of Cardiology, Yokohama City University Medical Center

Brief Summary

There were no significant differences in the time courses of any inflammatory marker between rivaroxaban and dabigatran treatment in patients with AF.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-14
• Study Completion: 2015-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

(1)stroke or systemic embolism within 6 months before enrollment (2)acute coronary syndromes or peripheral artery disease within 6 months before enrollment (3)acute heart failure (4)severe chronic renal failure (creatinine clearance < 30mL/min.) (5)receiving dual antiplatelet therapy (6)patients with a body weight of 50kg or less (7)uncontrolled hypertention (8)active malignancy (9)patients undergoing surgery within 6 months before enrollment (10)collagen disease (11)infectious disease (12)patients who are planned to undergoing catheter ablation for atrial fibrillation (13)contraindication of rivaroxaban or dabigatran (14)patients who are not allowed to participate in the trial by judgement of the treating physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
(1)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 (2)frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism) (3)frequency of 12-month major bleeding (defined as ISTH criteria)