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Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

Information source: Yokohama City University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Rivaroxaban (Drug); Dabigatran (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Yokohama City University Medical Center

Official(s) and/or principal investigator(s):
Kazuo Kimura, MD, Principal Investigator, Affiliation: Yokohama City University Medical Center

Overall contact:
Kengo Tsukahara, MD, Phone: 81-45-261-5656, Email: k-tsuka@urahp.yokohama-cu.ac.jp

Summary

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

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: 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

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.

Eligibility

Minimum age: 20 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

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

Ashigara Kami Hospital, Ashigaura, Kanagawa 258-0003, Japan; Recruiting
Izumi Kobayashi, MD, Phone: 81-465-83-0351, Email: eno_r@hotmail.com
Izumi Kobayashi, MD, Principal Investigator

Chigasaki Municipal Hospital, Chigasaki, Kanagawa 253-0042, Japan; Recruiting
Atsushi Wada, MD, Phone: 81-467-52-1111, Email: Chigasaki-circ@hotmail.co.jp
Atsushi Wada, MD, Principal Investigator

Fujisawa City Hospital, Fujisawa, Kanagawa 251-8550, Japan; Recruiting
Hideo Himeno, MD, Phone: 81-466-25-3111, Email: hdohimeno@jcom.home.ne.jp
Hideo Himeno, MD, Principal Investigator

Fujisawa Shounandai Hospital, Fujisawa, Kanagawa 252-0802, Japan; Recruiting
Takahiro Takei, MD, Phone: 81-466-44-1451, Email: t_takei@fj-shounandai.or.jp
Takahiro Takei, MD, Principal Investigator

Hadano Red Cross Hospital, Hadano, Kanagawa 257-0017, Japan; Recruiting
Reimin Sawada, MD, Phone: 81-463-81-3721, Email: rsawada@live.jp
Reimin Sawada, MD, Principal Investigator

National Hospital Organization Sagamihara National Hospital, Sagamihara, Kanagawa 252-0392, Japan; Recruiting
Yukiko Morita, MD, Phone: 81-42-742-8311, Email: y-morita@sagamihara-hosp.gr.jp
Yukiko Morita, MD, Principal Investigator

International Goodwill Hospital, Yokohama, Kanagawa 245-0006, Japan; Recruiting
Makoto Shimizu, MD, Phone: 81-45-813-0221, Email: makotoshimizuyaizu@gmail.com
Makoto Shimizu, MD, Principal Investigator

Kanagawa Cardiovascular and Respiratory Disease Center, Yokohama, Kanagawa 236-0051, Japan; Recruiting
Kazuki Fukui, MD, Phone: 81-45-701-9581, Email: Fukui@kanagawa-junko.jp
Kazuki Fukui, MD, Principal Investigator

Nagatsuta kousei general hospital, Yokohama, Kanagawa 226-0027, Japan; Recruiting
Takeshi Takamura, MD, Phone: 81-45-981-1201, Email: tkmrt@yokohama-cu.ac.jp
Takeshi Takamura, MD, Principal Investigator

Saiseikai Yokohama City Southern Hospital, Yokohama, Kanagawa 234-8503, Japan; Recruiting
Tsutomu Endo, MD, Phone: 81-45-832-1111, Email: endotu@nanbu.saiseikai.or.jp
Tsutomu Endo, MD, Principal Investigator

Yokohama City University Hospital, Yokohama, Kanagawa, Japan; Recruiting
Teruyasu Sugano, MD, Phone: 81-45-787-2800, Email: t_sugano@yokohama-cu.ac.jp
Teruyasu Sugano, MD, Principal Investigator

Yokohama City University Medical Center, Yokohama, Kanagawa 232-0024, Japan; Recruiting
Kazuo Kimura, MD, Phone: 81-45-261-5656, Email: c-kimura@urahp.yokohama-cu.ac.jp
Kazuo Kimura, MD, Principal Investigator
Kengo Tsukahara, MD, Sub-Investigator

Yokohama Seamen's Insurance Hospital, Yokohama, Kanagawa 240-8585, Japan; Recruiting
Shunichi Kobayashi, MD, Phone: 81-45-331-1251, Email: shunichi_kobayashi@sempos.or.jp
Shunichi Kobayashi, MD, Principal Investigator

Yokosuka City hospital, Yokosuka, Kanagawa 240-0195, Japan; Recruiting
Jun Okuda, MD, Phone: 81-46-856-3136, Email: jokudajun@yahoo.co.jp
Jun Okuda, MD, Principal Investigator

International University of Health and Welfare Atami Hospital, Atami, Shizuoka 413-0012, Japan; Recruiting
Tomohiko Shigemasa, MD, Phone: 81-557-81-9171, Email: tshig@iuhw.ac.jp
Tomohiko Shigemasa, MD, Principal Investigator

Omori Red Cross Hospital, Ohta, Tokyo 143-8527, Japan; Recruiting
Yasuyuki Mochida, MD, Phone: 81-3-3775-3111, Email: y-mochi@u01.gate01.com
Yasuyuki Mochida, MD, Principal Investigator

Additional Information

Starting date: July 2013
Last updated: August 4, 2015

Page last updated: August 23, 2015

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