Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran (RIVAL-AF)

August 4, 2015 updated by: Kiyoshi Hibi, Yokohama City University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Kanagawa
      • Ashigaura, Kanagawa, Japan, 258-0003
        • Recruiting
        • Ashigara Kami Hospital
        • Contact:
        • Principal Investigator:
          • Izumi Kobayashi, MD
      • Chigasaki, Kanagawa, Japan, 253-0042
        • Recruiting
        • Chigasaki Municipal Hospital
        • Contact:
        • Principal Investigator:
          • Atsushi Wada, MD
      • Fujisawa, Kanagawa, Japan, 251-8550
        • Recruiting
        • Fujisawa City Hospital
        • Contact:
        • Principal Investigator:
          • Hideo Himeno, MD
      • Fujisawa, Kanagawa, Japan, 252-0802
        • Recruiting
        • Fujisawa Shounandai Hospital
        • Contact:
        • Principal Investigator:
          • Takahiro Takei, MD
      • Hadano, Kanagawa, Japan, 257-0017
        • Recruiting
        • Hadano Red Cross Hospital
        • Contact:
        • Principal Investigator:
          • Reimin Sawada, MD
      • Sagamihara, Kanagawa, Japan, 252-0392
        • Recruiting
        • National Hospital Organization Sagamihara National Hospital
        • Contact:
        • Principal Investigator:
          • Yukiko Morita, MD
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
        • Contact:
        • Principal Investigator:
          • Kazuo Kimura, MD
        • Sub-Investigator:
          • Kengo Tsukahara, MD
      • Yokohama, Kanagawa, Japan, 226-0027
        • Recruiting
        • Nagatsuta kousei general hospital
        • Contact:
        • Principal Investigator:
          • Takeshi Takamura, MD
      • Yokohama, Kanagawa, Japan, 234-8503
        • Recruiting
        • Saiseikai Yokohama City Southern Hospital
        • Contact:
        • Principal Investigator:
          • Tsutomu Endo, MD
      • Yokohama, Kanagawa, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Disease Center
        • Contact:
        • Principal Investigator:
          • Kazuki Fukui, MD
      • Yokohama, Kanagawa, Japan, 240-8585
        • Recruiting
        • Yokohama Seamen's Insurance Hospital
        • Contact:
        • Principal Investigator:
          • Shunichi Kobayashi, MD
      • Yokohama, Kanagawa, Japan, 245-0006
        • Recruiting
        • International Goodwill Hospital
        • Contact:
        • Principal Investigator:
          • Makoto Shimizu, MD
      • Yokohama, Kanagawa, Japan
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
        • Principal Investigator:
          • Teruyasu Sugano, MD
      • Yokosuka, Kanagawa, Japan, 240-0195
        • Recruiting
        • Yokosuka City hospital
        • Contact:
        • Principal Investigator:
          • Jun Okuda, MD
    • Shizuoka
      • Atami, Shizuoka, Japan, 413-0012
        • Recruiting
        • International University of Health and Welfare Atami Hospital
        • Contact:
        • Principal Investigator:
          • Tomohiko Shigemasa, MD
    • Tokyo
      • Ohta, Tokyo, Japan, 143-8527
        • Recruiting
        • Omori Red Cross Hospital
        • Contact:
        • Principal Investigator:
          • Yasuyuki Mochida, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • Xarelto
Active Comparator: 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.
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.
Other Names:
  • Pradaxa

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome 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
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome 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)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yokohama City University Medical Center

Collaborators

Yokohama City University

Investigators

  • Principal Investigator: Kazuo Kimura, MD, Yokohama City University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 5, 2014

First Submitted That Met QC Criteria

January 3, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kimura5656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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