Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran
- Registration Number
- NCT02331602
- Lead Sponsor
- Yokohama City University Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- non-valvular atrial fibrillation
- a CHADS2-VASc score of 1 or more
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rivaroxaban 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. dabigatran 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (16)
Omori Red Cross Hospital
🇯🇵Ohta, Tokyo, Japan
International Goodwill Hospital
🇯🇵Yokohama, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Yokosuka City hospital
🇯🇵Yokosuka, Kanagawa, Japan
International University of Health and Welfare Atami Hospital
🇯🇵Atami, Shizuoka, Japan
National Hospital Organization Sagamihara National Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Disease Center
🇯🇵Yokohama, Kanagawa, Japan
Yokohama Seamen's Insurance Hospital
🇯🇵Yokohama, Kanagawa, Japan
Ashigara Kami Hospital
🇯🇵Ashigaura, Kanagawa, Japan
Fujisawa Shounandai Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Hadano Red Cross Hospital
🇯🇵Hadano, Kanagawa, Japan
Nagatsuta kousei general hospital
🇯🇵Yokohama, Kanagawa, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Saiseikai Yokohama City Southern Hospital
🇯🇵Yokohama, Kanagawa, Japan
Chigasaki Municipal Hospital
🇯🇵Chigasaki, Kanagawa, Japan