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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Rivaroxaban
Dabigatran
Sponsored by
Yokohama City University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, anticoagulation, inflammation

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ashigara Kami HospitalRecruiting
  • Chigasaki Municipal HospitalRecruiting
  • Fujisawa City HospitalRecruiting
  • Fujisawa Shounandai HospitalRecruiting
  • Hadano Red Cross HospitalRecruiting
  • National Hospital Organization Sagamihara National HospitalRecruiting
  • Nagatsuta kousei general hospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Saiseikai Yokohama City Southern HospitalRecruiting
  • Kanagawa Cardiovascular and Respiratory Disease CenterRecruiting
  • Yokohama Seamen's Insurance HospitalRecruiting
  • International Goodwill HospitalRecruiting
  • Yokohama City University HospitalRecruiting
  • Yokosuka City hospitalRecruiting
  • International University of Health and Welfare Atami HospitalRecruiting
  • Omori Red Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

rivaroxaban

dabigatran

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2014
Last Updated
August 4, 2015
Sponsor
Yokohama City University Medical Center
Collaborators
Yokohama City University
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1. Study Identification

Unique Protocol Identification Number
NCT02331602
Brief Title
Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran
Acronym
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-
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yokohama City University Medical Center
Collaborators
Yokohama City University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, anticoagulation, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rivaroxaban
Arm Type
Active Comparator
Arm Description
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.
Arm Title
dabigatran
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Pradaxa
Intervention Description
Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kengo Tsukahara, MD
Phone
81-45-261-5656
Email
k-tsuka@urahp.yokohama-cu.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuo Kimura, MD
Organizational Affiliation
Yokohama City University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashigara Kami Hospital
City
Ashigaura
State/Province
Kanagawa
ZIP/Postal Code
258-0003
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izumi Kobayashi, MD
Phone
81-465-83-0351
Email
eno_r@hotmail.com
First Name & Middle Initial & Last Name & Degree
Izumi Kobayashi, MD
Facility Name
Chigasaki Municipal Hospital
City
Chigasaki
State/Province
Kanagawa
ZIP/Postal Code
253-0042
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Wada, MD
Phone
81-467-52-1111
Email
Chigasaki-circ@hotmail.co.jp
First Name & Middle Initial & Last Name & Degree
Atsushi Wada, MD
Facility Name
Fujisawa City Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideo Himeno, MD
Phone
81-466-25-3111
Email
hdohimeno@jcom.home.ne.jp
First Name & Middle Initial & Last Name & Degree
Hideo Himeno, MD
Facility Name
Fujisawa Shounandai Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
252-0802
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Takei, MD
Phone
81-466-44-1451
Email
t_takei@fj-shounandai.or.jp
First Name & Middle Initial & Last Name & Degree
Takahiro Takei, MD
Facility Name
Hadano Red Cross Hospital
City
Hadano
State/Province
Kanagawa
ZIP/Postal Code
257-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reimin Sawada, MD
Phone
81-463-81-3721
Email
rsawada@live.jp
First Name & Middle Initial & Last Name & Degree
Reimin Sawada, MD
Facility Name
National Hospital Organization Sagamihara National Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukiko Morita, MD
Phone
81-42-742-8311
Email
y-morita@sagamihara-hosp.gr.jp
First Name & Middle Initial & Last Name & Degree
Yukiko Morita, MD
Facility Name
Nagatsuta kousei general hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
226-0027
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takeshi Takamura, MD
Phone
81-45-981-1201
Email
tkmrt@yokohama-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Takeshi Takamura, MD
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuo Kimura, MD
Phone
81-45-261-5656
Email
c-kimura@urahp.yokohama-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Kazuo Kimura, MD
First Name & Middle Initial & Last Name & Degree
Kengo Tsukahara, MD
Facility Name
Saiseikai Yokohama City Southern Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
234-8503
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsutomu Endo, MD
Phone
81-45-832-1111
Email
endotu@nanbu.saiseikai.or.jp
First Name & Middle Initial & Last Name & Degree
Tsutomu Endo, MD
Facility Name
Kanagawa Cardiovascular and Respiratory Disease Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuki Fukui, MD
Phone
81-45-701-9581
Email
Fukui@kanagawa-junko.jp
First Name & Middle Initial & Last Name & Degree
Kazuki Fukui, MD
Facility Name
Yokohama Seamen's Insurance Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
240-8585
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunichi Kobayashi, MD
Phone
81-45-331-1251
Email
shunichi_kobayashi@sempos.or.jp
First Name & Middle Initial & Last Name & Degree
Shunichi Kobayashi, MD
Facility Name
International Goodwill Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-0006
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makoto Shimizu, MD
Phone
81-45-813-0221
Email
makotoshimizuyaizu@gmail.com
First Name & Middle Initial & Last Name & Degree
Makoto Shimizu, MD
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teruyasu Sugano, MD
Phone
81-45-787-2800
Email
t_sugano@yokohama-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Teruyasu Sugano, MD
Facility Name
Yokosuka City hospital
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
240-0195
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Okuda, MD
Phone
81-46-856-3136
Email
jokudajun@yahoo.co.jp
First Name & Middle Initial & Last Name & Degree
Jun Okuda, MD
Facility Name
International University of Health and Welfare Atami Hospital
City
Atami
State/Province
Shizuoka
ZIP/Postal Code
413-0012
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomohiko Shigemasa, MD
Phone
81-557-81-9171
Email
tshig@iuhw.ac.jp
First Name & Middle Initial & Last Name & Degree
Tomohiko Shigemasa, MD
Facility Name
Omori Red Cross Hospital
City
Ohta
State/Province
Tokyo
ZIP/Postal Code
143-8527
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuyuki Mochida, MD
Phone
81-3-3775-3111
Email
y-mochi@u01.gate01.com
First Name & Middle Initial & Last Name & Degree
Yasuyuki Mochida, MD

12. IPD Sharing Statement

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Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

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