A Phase 4 interventional study of Rivaroxaban and Dabigatran in Atrial Fibrillation, sponsored by Yokohama City University Medical Center. Status unknown at 16 sites in Japan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-08-06.
Sponsored by Yokohama City University Medical Center · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.
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.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 200 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Yokohama City University Medical Center is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Rivaroxaban
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.
Drug: Dabigatran
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.
Also known as: Xarelto
Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.
Also known as: Pradaxa
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
Time frame: 12 months
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
Time frame: 12 months
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)
Time frame: 12 months
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Yokohama City University Medical Center