Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

Atrial Fibrillation Clinical Trial

— RIVAL-AF  

Official title:

Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study-

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331602
• Other study ID #: Kimura5656
• Status: Recruiting
• Phase: Phase 4
• First received: January 5, 2014
• Last updated: August 4, 2015
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Yokohama City University Medical Center
• Contact: Kengo Tsukahara, MD
• Phone: 81-45-261-5656
• Email: k-tsuka[@]urahp.yokohama-cu.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Ashigara Kami Hospital	Ashigaura	Kanagawa
Japan	International University of Health and Welfare Atami Hospital	Atami	Shizuoka
Japan	Chigasaki Municipal Hospital	Chigasaki	Kanagawa
Japan	Fujisawa City Hospital	Fujisawa	Kanagawa
Japan	Fujisawa Shounandai Hospital	Fujisawa	Kanagawa
Japan	Hadano Red Cross Hospital	Hadano	Kanagawa
Japan	Omori Red Cross Hospital	Ohta	Tokyo
Japan	National Hospital Organization Sagamihara National Hospital	Sagamihara	Kanagawa
Japan	International Goodwill Hospital	Yokohama	Kanagawa
Japan	Kanagawa Cardiovascular and Respiratory Disease Center	Yokohama	Kanagawa
Japan	Nagatsuta kousei general hospital	Yokohama	Kanagawa
Japan	Saiseikai Yokohama City Southern Hospital	Yokohama	Kanagawa
Japan	Yokohama City University Hospital	Yokohama	Kanagawa
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Japan	Yokohama Seamen's Insurance Hospital	Yokohama	Kanagawa
Japan	Yokosuka City hospital	Yokosuka	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Yokohama City University Medical Center	Yokohama City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	No
Secondary	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	No