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Research on the development of an index for bleeding and thrombosis risk during direct oral anticoagulant treatment

Research Project

Project/Area Number 18K07473
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 52010:General internal medicine-related
Research InstitutionHealth Sciences University of Hokkaido

Principal Investigator

Ohmura Kazumasa  北海道医療大学, 予防医療科学センター, 准教授 (10803637)

Co-Investigator(Kenkyū-buntansha) 家子 正裕  北海道医療大学, 歯学部, 教授 (50250436)
高橋 伸彦  北海道医療大学, 歯学部, 教授 (20372279)
Project Period (FY) 2018-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2020: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2019: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2018: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Keywords直接経口抗凝固薬 / 確認試験 / 血栓リスク / 出血リスク / 残存抗凝固能 / 希釈プロトロンビン時間 / 出血マーカー / 血栓マーカー / 血栓塞栓症 / Xa阻害薬 / 確認検査 / 出血イベント
Outline of Final Research Achievements

In patients with non-valvular atrial fibrillation treated with direct oral anticoagulant treatment, parameters of coagulation and anticoagulation functions were measured using blood samples collected, and then the correlation with the Ratio of Inhibited Thrombin Generation (RITG), an indicator of bleeding and thrombosis risk, was examined. High RITG levels were associated with a significant increase in bleeding risk markers, while low RITG levels were associated with a significant increase in thrombosis risk markers. This study suggests that RITG is useful as an indicator for evaluating thrombosis or bleeding risk during direct oral anticoagulant treatment, and the results will contribute to the establishment of a new confirmation test for the implementation of appropriate anticoagulant therapy.

Academic Significance and Societal Importance of the Research Achievements

直接経口抗凝固薬(DOAC)による治療は非弁膜症心房細動を含め静脈性血栓性疾患で広く行われている治療であり、従来のワルファリン療法と比較し、治療中の確認試験を必要としない点、頭蓋内出血などの重大な出血リスクが少ない点で優れているとされる。確認試験を必要としない点から定容量で使用されるが、一方で患者個々の凝固能および抗凝固能の多様性を考慮するとDOACの抗凝固効果が均一であるとは考えにくい。本研究は、DOAC療法中の抗凝固能を評価する指標を作成することに研究成果が寄与することで、血栓リスクあるいは出血リスクが高いと推測される状況で実施できる確認試験の開発を前進させる意義がある。

Report

(7 results)
  • 2023 Annual Research Report   Final Research Report ( PDF )
  • 2022 Research-status Report
  • 2021 Research-status Report
  • 2020 Research-status Report
  • 2019 Research-status Report
  • 2018 Research-status Report
  • Research Products

    (5 results)

All 2023 2020 2019

All Journal Article (1 results) (of which Peer Reviewed: 1 results) Presentation (4 results) (of which Int'l Joint Research: 2 results,  Invited: 1 results)

  • [Journal Article] Novel assay based on diluted prothrombin time reflects anticoagulant effects of direct oral factor Xa inhibitors: Results of multicenter study in Japan2020

    • Author(s)
      Ieko Masahiro、Ohmura Kazumasa、Naito Sumiyoshi、Yoshida Mika、Sakuma Ichiro、Ikeda Kozue、Ono Shouko、Suzuki Takeshi、Takahashi Nobuhiko
    • Journal Title

      Thrombosis Research

      Volume: 195 Pages: 158-164

    • DOI

      10.1016/j.thromres.2020.07.020

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Presentation] DOAC療法下での出血リスクの評価と確認試験2023

    • Author(s)
      大村一将
    • Organizer
      第17回 日本血栓止血学会 学術標準化委員会シンポジウム
    • Related Report
      2023 Annual Research Report
    • Invited
  • [Presentation] 経口抗凝固薬内服患者におけるGDF-15測定値の臨床的特徴2023

    • Author(s)
      大村一将
    • Organizer
      第46回 日本血栓止血学会学術集会
    • Related Report
      2023 Annual Research Report
  • [Presentation] Measuring the Anticoagulant Effect of Direct Oral Anticoagulants Targeted to Factor Xa Using the Ratio of Inhibited Thrombin Generation based on Dilute Prothrombin Time: Results from Multicenter Study2019

    • Author(s)
      Kazumasa Ohmura, Masahiro Ieko, Sumiyoshi Naito, Mika Yoshida, Takeshi Suzuki, Nobuhiko Takahashi, Shoko Ono, Kozue Ikeda, Ichiro Sakuma
    • Organizer
      The XXVII Congress of the International Society on Thrombosis and Haemostatis
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research
  • [Presentation] Dilute prothrombin time is associated with the plasma drug concentrations, contributing to be comparable with anticoagulant effects as a measuring test for Direct oral anticoagulants targeted to factor Xa therapy: Results from multicenter study2019

    • Author(s)
      Kazumasa Ohmura, Masahiro Ieko, Sumiyoshi Naito, Mika Yoshida, Takeshi Suzuki, Nobuhiko Takahashi, Shoko Ono, Kozue Ikeda, Ichiro Sakuma
    • Organizer
      XXXII International Symposium on Technical Innovations in Laboratory Hematology
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research

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Published: 2018-04-23   Modified: 2025-01-30  

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