Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, anticoagulation, inflammation
Brief summary
The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.
Detailed 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.
Interventions
DRUGRivaroxaban
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.
DRUGDabigatran
Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.
Sponsors
Yokohama City University
Yokohama City University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism)and frequency of 12-month major bleeding (defined as ISTH criteria) | 12 months |
Countries
Japan
Contacts
Primary ContactKengo Tsukahara, MD
Outcome results
None listed