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Trial record 30 of 332 for:    DABIGATRAN

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

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ClinicalTrials.gov Identifier: NCT02331602
Recruitment Status : Unknown
Verified August 2015 by Kiyoshi Hibi, Yokohama City University Medical Center.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : August 6, 2015
Sponsor:
Collaborator:
Yokohama City University
Information provided by (Responsible Party):
Kiyoshi Hibi, Yokohama City University Medical Center

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Rivaroxaban Drug: Dabigatran Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015


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 Name: 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 Name: Pradaxa




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 Outcome Measures:
  1. 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 ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331602


Contacts
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Contact: Kengo Tsukahara, MD 81-45-261-5656 k-tsuka@urahp.yokohama-cu.ac.jp

Locations
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Japan
Ashigara Kami Hospital Recruiting
Ashigaura, Kanagawa, Japan, 258-0003
Contact: Izumi Kobayashi, MD    81-465-83-0351    eno_r@hotmail.com   
Principal Investigator: Izumi Kobayashi, MD         
Chigasaki Municipal Hospital Recruiting
Chigasaki, Kanagawa, Japan, 253-0042
Contact: Atsushi Wada, MD    81-467-52-1111    Chigasaki-circ@hotmail.co.jp   
Principal Investigator: Atsushi Wada, MD         
Fujisawa City Hospital Recruiting
Fujisawa, Kanagawa, Japan, 251-8550
Contact: Hideo Himeno, MD    81-466-25-3111    hdohimeno@jcom.home.ne.jp   
Principal Investigator: Hideo Himeno, MD         
Fujisawa Shounandai Hospital Recruiting
Fujisawa, Kanagawa, Japan, 252-0802
Contact: Takahiro Takei, MD    81-466-44-1451    t_takei@fj-shounandai.or.jp   
Principal Investigator: Takahiro Takei, MD         
Hadano Red Cross Hospital Recruiting
Hadano, Kanagawa, Japan, 257-0017
Contact: Reimin Sawada, MD    81-463-81-3721    rsawada@live.jp   
Principal Investigator: Reimin Sawada, MD         
National Hospital Organization Sagamihara National Hospital Recruiting
Sagamihara, Kanagawa, Japan, 252-0392
Contact: Yukiko Morita, MD    81-42-742-8311    y-morita@sagamihara-hosp.gr.jp   
Principal Investigator: Yukiko Morita, MD         
Nagatsuta kousei general hospital Recruiting
Yokohama, Kanagawa, Japan, 226-0027
Contact: Takeshi Takamura, MD    81-45-981-1201    tkmrt@yokohama-cu.ac.jp   
Principal Investigator: Takeshi Takamura, MD         
Yokohama City University Medical Center Recruiting
Yokohama, Kanagawa, Japan, 232-0024
Contact: Kazuo Kimura, MD    81-45-261-5656    c-kimura@urahp.yokohama-cu.ac.jp   
Principal Investigator: Kazuo Kimura, MD         
Sub-Investigator: Kengo Tsukahara, MD         
Saiseikai Yokohama City Southern Hospital Recruiting
Yokohama, Kanagawa, Japan, 234-8503
Contact: Tsutomu Endo, MD    81-45-832-1111    endotu@nanbu.saiseikai.or.jp   
Principal Investigator: Tsutomu Endo, MD         
Kanagawa Cardiovascular and Respiratory Disease Center Recruiting
Yokohama, Kanagawa, Japan, 236-0051
Contact: Kazuki Fukui, MD    81-45-701-9581    Fukui@kanagawa-junko.jp   
Principal Investigator: Kazuki Fukui, MD         
Yokohama Seamen's Insurance Hospital Recruiting
Yokohama, Kanagawa, Japan, 240-8585
Contact: Shunichi Kobayashi, MD    81-45-331-1251    shunichi_kobayashi@sempos.or.jp   
Principal Investigator: Shunichi Kobayashi, MD         
International Goodwill Hospital Recruiting
Yokohama, Kanagawa, Japan, 245-0006
Contact: Makoto Shimizu, MD    81-45-813-0221    makotoshimizuyaizu@gmail.com   
Principal Investigator: Makoto Shimizu, MD         
Yokohama City University Hospital Recruiting
Yokohama, Kanagawa, Japan
Contact: Teruyasu Sugano, MD    81-45-787-2800    t_sugano@yokohama-cu.ac.jp   
Principal Investigator: Teruyasu Sugano, MD         
Yokosuka City hospital Recruiting
Yokosuka, Kanagawa, Japan, 240-0195
Contact: Jun Okuda, MD    81-46-856-3136    jokudajun@yahoo.co.jp   
Principal Investigator: Jun Okuda, MD         
International University of Health and Welfare Atami Hospital Recruiting
Atami, Shizuoka, Japan, 413-0012
Contact: Tomohiko Shigemasa, MD    81-557-81-9171    tshig@iuhw.ac.jp   
Principal Investigator: Tomohiko Shigemasa, MD         
Omori Red Cross Hospital Recruiting
Ohta, Tokyo, Japan, 143-8527
Contact: Yasuyuki Mochida, MD    81-3-3775-3111    y-mochi@u01.gate01.com   
Principal Investigator: Yasuyuki Mochida, MD         
Sponsors and Collaborators
Yokohama City University Medical Center
Yokohama City University
Investigators
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Principal Investigator: Kazuo Kimura, MD Yokohama City University Medical Center

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Responsible Party: Kiyoshi Hibi, Associate Professor, Division of Cardiology, Yokohama City University Medical Center
ClinicalTrials.gov Identifier: NCT02331602     History of Changes
Other Study ID Numbers: Kimura5656
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Keywords provided by Kiyoshi Hibi, Yokohama City University Medical Center:
atrial fibrillation
anticoagulation
inflammation
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Anti-Inflammatory Agents
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants