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Atrial FibrillationPhase 4RIVAL-AFNCT02331602

Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

A Phase 4 study testing Rivaroxaban and Dabigatran in people with Atrial Fibrillation, run by Yokohama City University Medical Center at 16 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Rivaroxaban and Dabigatran
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
16 sitesJapan
Study dates
Jul 2013to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • non-valvular atrial fibrillation
  • a CHADS2-VASc score of 1 or more

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

Kengo Tsukahara, MD contact

81-45-261-5656

k-tsuka@urahp.yokohama-cu.ac.jp

16 sites in 1 country

Japan16 sites, 16 recruiting

  • Ashigara Kami Hospital

    Ashigaura, Kanagawa, 258-0003

    Izumi Kobayashi, MD, 81-465-83-0351, eno_r@hotmail.com

    Izumi Kobayashi, MD

    Recruiting

  • International University of Health and Welfare Atami Hospital

    Atami, Shizuoka, 413-0012

    Tomohiko Shigemasa, MD, 81-557-81-9171, tshig@iuhw.ac.jp

    Tomohiko Shigemasa, MD

    Recruiting

  • Chigasaki Municipal Hospital

    Chigasaki, Kanagawa, 253-0042

    Atsushi Wada, MD, 81-467-52-1111, Chigasaki-circ@hotmail.co.jp

    Atsushi Wada, MD

    Recruiting

  • Fujisawa City Hospital

    Fujisawa, Kanagawa, 251-8550

    Hideo Himeno, MD, 81-466-25-3111, hdohimeno@jcom.home.ne.jp

    Hideo Himeno, MD

    Recruiting

  • Fujisawa Shounandai Hospital

    Fujisawa, Kanagawa, 252-0802

    Takahiro Takei, MD, 81-466-44-1451, t_takei@fj-shounandai.or.jp

    Takahiro Takei, MD

    Recruiting

  • Hadano Red Cross Hospital

    Hadano, Kanagawa, 257-0017

    Reimin Sawada, MD, 81-463-81-3721, rsawada@live.jp

    Reimin Sawada, MD

    Recruiting

  • Omori Red Cross Hospital

    Ohta, Tokyo, 143-8527

    Yasuyuki Mochida, MD, 81-3-3775-3111, y-mochi@u01.gate01.com

    Yasuyuki Mochida, MD

    Recruiting

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa, 252-0392

    Yukiko Morita, MD, 81-42-742-8311, y-morita@sagamihara-hosp.gr.jp

    Yukiko Morita, MD

    Recruiting

  • Nagatsuta kousei general hospital

    Yokohama, Kanagawa, 226-0027

    Takeshi Takamura, MD, 81-45-981-1201, tkmrt@yokohama-cu.ac.jp

    Takeshi Takamura, MD

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

    Kazuo Kimura, MD, 81-45-261-5656, c-kimura@urahp.yokohama-cu.ac.jp

    Kazuo Kimura, MD

    Recruiting

  • Saiseikai Yokohama City Southern Hospital

    Yokohama, Kanagawa, 234-8503

    Tsutomu Endo, MD, 81-45-832-1111, endotu@nanbu.saiseikai.or.jp

    Tsutomu Endo, MD

    Recruiting

  • Kanagawa Cardiovascular and Respiratory Disease Center

    Yokohama, Kanagawa, 236-0051

    Kazuki Fukui, MD, 81-45-701-9581, Fukui@kanagawa-junko.jp

    Kazuki Fukui, MD

    Recruiting

  • Yokohama Seamen's Insurance Hospital

    Yokohama, Kanagawa, 240-8585

    Shunichi Kobayashi, MD, 81-45-331-1251, shunichi_kobayashi@sempos.or.jp

    Shunichi Kobayashi, MD

    Recruiting

  • International Goodwill Hospital

    Yokohama, Kanagawa, 245-0006

    Makoto Shimizu, MD, 81-45-813-0221, makotoshimizuyaizu@gmail.com

    Makoto Shimizu, MD

    Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa

    Teruyasu Sugano, MD, 81-45-787-2800, t_sugano@yokohama-cu.ac.jp

    Teruyasu Sugano, MD

    Recruiting

  • Yokosuka City hospital

    Yokosuka, Kanagawa, 240-0195

    Jun Okuda, MD, 81-46-856-3136, jokudajun@yahoo.co.jp

    Jun Okuda, MD

    Recruiting

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Being tested
Rivaroxaban, Dabigatran
Keywords
atrial fibrillation, anticoagulation, inflammation
Medical subject headings
Atrial Fibrillation, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    Also called Xarelto

    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.

  • DabigatranDrug

    Also called Pradaxa

    Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.

Study groups in NCT02331602
Study groupRoleWhat they receive
rivaroxabanActive comparatorPatients 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.
Receives: Drug: Rivaroxaban
dabigatranActive comparatorPatients 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.
Receives: Drug: Dabigatran

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (1)

  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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02331602
Sponsor's protocol ID
Kimura5656
Acronym
RIVAL-AF
Status last verified
Aug 2015
First submitted
5 Jan 2014
Last updated
6 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivaroxaban and Dabigatran in people with Atrial Fibrillation, run by Yokohama City University Medical Center at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kengo Tsukahara, MD (81-45-261-5656, k-tsuka@urahp.yokohama-cu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02331602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.

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