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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yokohama City University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yokohama City University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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