Trials / Unknown
UnknownNCT02331602
Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran
Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study-
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Yokohama City University Medical Center · Academic / Other
- Sex
- All
- Age
- 20 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban | 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. |
| DRUG | Dabigatran | Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2015-10-01
- Completion
- 2015-12-01
- First posted
- 2015-01-06
- Last updated
- 2015-08-06
Locations
16 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02331602. Inclusion in this directory is not an endorsement.