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6. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy

Author

Kotaka, Masahito, Saito, Yoji, Kato, Takeshi, Satake, Hironaga, Makiyama, Akitaka, Tsuji, Yasushi, Shinozaki, Katsunori, Fujiwara, Toshiyoshi, Mizushima, Tsunekazu, Harihara, Yasushi, Nagata, Naoki, Kurihara, Naoto, Ando, Masahiko, Kusakawa, Genichi, Sakai, Takumi, Uchida, Yugo, Takamoto, Mikihiro, Kimoto, Saki, and Hyodo, Ichinosuke

Published
2020
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7. Conduction velocity mapping in atrial fibrillation using omnipolar technology.

Author

Okubo, Yousaku, Oguri, Naoto, Sakai, Takumi, Uotani, Yukimi, Furutani, Motoki, Miyamoto, Shogo, Miyauchi, Shunsuke, Okamura, Sho, Tokuyama, Takehito, and Nakano, Yukiko

Subjects
CONFIDENCE intervals, SCIENTIFIC observation, MULTIVARIATE analysis, ATRIAL fibrillation, MEDICAL technology, CATHETER ablation, DISEASE relapse, DESCRIPTIVE statistics, PULMONARY veins, HEART conduction system, LONGITUDINAL method
Abstract

Background: Recent studies have shown that atrial slow conduction velocity (CV) is associated with the perpetuation of atrial fibrillation (AF). However, the criteria of CV measurement have not been standardized. The aim of this study was to evaluate the relationship between the slow CV area (SCVA) measured by novel omnipolar technology (OT) and AF recurrence. Methods: This study included 90 patients with AF who underwent initial pulmonary vein isolation (PVI). The segmented surface area of the SCVA was measured by left atrial (LA) electrophysiological mapping using OT before the PVI. The proportion of the SCVA at each cutoff value of CV (from < 0.6 to < 0.9 m/s) was compared between the patients with and without AF recurrence. Results: During a mean follow‐up period of 516 ± 197 days, the recurrence of AF after the initial PVI was observed in 23 (25.5%) patients. In patients with AF recurrence, the proportion of the SCVA in the LA posterior, LA appendage (LAA), and LA anterior were significantly higher than those without AF recurrence. The multivariate analysis indicated that the proportion of the low voltage area and the SCVA in the LA anterior (local CV < 0.7 m/s) were independent predictors of AF recurrence (hazard ratio [HR], 1.07; 95% confidence interval [CI], 1.01–1.14; p = 0.03; HR, 1.40; 95% CI, 1.07–1.83; p = 0.01, respectively). Conclusion: By evaluating the local CV using OT, it was indicated that SCVA with CV < 0.7 m/s in the LA anterior is strongly associated with AF recurrence after PVI. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Correction to: A placebo‑controlled, double‑blind, randomized study of recombinant thrombomodulin (ART‑123) to prevent oxaliplatin‑induced peripheral neuropathy

Author

Kotaka, Masahito, Saito, Yoji, Kato, Takeshi, Satake, Hironaga, Makiyama, Akitaka, Tsuji, Yasushi, Shinozaki, Katsunori, Fujiwara, Toshiyoshi, Mizushima, Tsunekazu, Harihara, Yasushi, Nagata, Naoki, Kurihara, Naoto, Ando, Masahiko, Kusakawa, Genichi, Sakai, Takumi, Uchida, Yugo, Takamoto, Mikihiro, Kimoto, Saki, and Hyodo, Ichinosuke

Published
2021
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10. Supplementary Figure 3 from Small-molecule inhibition of Wee1 kinase by MK-1775 selectively sensitizes p53-deficient tumor cells to DNA-damaging agents

Author

Hirai, Hiroshi, primary, Iwasawa, Yoshikazu, primary, Okada, Megumu, primary, Arai, Tsuyoshi, primary, Nishibata, Toshihide, primary, Kobayashi, Makiko, primary, Kimura, Toshifumi, primary, Kaneko, Naoki, primary, Ohtani, Junko, primary, Yamanaka, Kazunori, primary, Itadani, Hiraku, primary, Takahashi-Suzuki, Ikuko, primary, Fukasawa, Kazuhiro, primary, Oki, Hiroko, primary, Nambu, Tadahiro, primary, Jiang, Jian, primary, Sakai, Takumi, primary, Arakawa, Hiroharu, primary, Sakamoto, Toshihiro, primary, Sagara, Takeshi, primary, Yoshizumi, Takashi, primary, Mizuarai, Shinji, primary, and Kotani, Hidehito, primary

Published
2023
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11. Supplementary Figure 1 from Small-molecule inhibition of Wee1 kinase by MK-1775 selectively sensitizes p53-deficient tumor cells to DNA-damaging agents

Author

Hirai, Hiroshi, primary, Iwasawa, Yoshikazu, primary, Okada, Megumu, primary, Arai, Tsuyoshi, primary, Nishibata, Toshihide, primary, Kobayashi, Makiko, primary, Kimura, Toshifumi, primary, Kaneko, Naoki, primary, Ohtani, Junko, primary, Yamanaka, Kazunori, primary, Itadani, Hiraku, primary, Takahashi-Suzuki, Ikuko, primary, Fukasawa, Kazuhiro, primary, Oki, Hiroko, primary, Nambu, Tadahiro, primary, Jiang, Jian, primary, Sakai, Takumi, primary, Arakawa, Hiroharu, primary, Sakamoto, Toshihiro, primary, Sagara, Takeshi, primary, Yoshizumi, Takashi, primary, Mizuarai, Shinji, primary, and Kotani, Hidehito, primary

Published
2023
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12. Supplementary Figure 4 from Small-molecule inhibition of Wee1 kinase by MK-1775 selectively sensitizes p53-deficient tumor cells to DNA-damaging agents

Author

Hirai, Hiroshi, primary, Iwasawa, Yoshikazu, primary, Okada, Megumu, primary, Arai, Tsuyoshi, primary, Nishibata, Toshihide, primary, Kobayashi, Makiko, primary, Kimura, Toshifumi, primary, Kaneko, Naoki, primary, Ohtani, Junko, primary, Yamanaka, Kazunori, primary, Itadani, Hiraku, primary, Takahashi-Suzuki, Ikuko, primary, Fukasawa, Kazuhiro, primary, Oki, Hiroko, primary, Nambu, Tadahiro, primary, Jiang, Jian, primary, Sakai, Takumi, primary, Arakawa, Hiroharu, primary, Sakamoto, Toshihiro, primary, Sagara, Takeshi, primary, Yoshizumi, Takashi, primary, Mizuarai, Shinji, primary, and Kotani, Hidehito, primary

Published
2023
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13. Supplementary Figure 2 from Small-molecule inhibition of Wee1 kinase by MK-1775 selectively sensitizes p53-deficient tumor cells to DNA-damaging agents

Author

Hirai, Hiroshi, primary, Iwasawa, Yoshikazu, primary, Okada, Megumu, primary, Arai, Tsuyoshi, primary, Nishibata, Toshihide, primary, Kobayashi, Makiko, primary, Kimura, Toshifumi, primary, Kaneko, Naoki, primary, Ohtani, Junko, primary, Yamanaka, Kazunori, primary, Itadani, Hiraku, primary, Takahashi-Suzuki, Ikuko, primary, Fukasawa, Kazuhiro, primary, Oki, Hiroko, primary, Nambu, Tadahiro, primary, Jiang, Jian, primary, Sakai, Takumi, primary, Arakawa, Hiroharu, primary, Sakamoto, Toshihiro, primary, Sagara, Takeshi, primary, Yoshizumi, Takashi, primary, Mizuarai, Shinji, primary, and Kotani, Hidehito, primary

Published
2023
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14. Supplementary Figure 1 from MK-5108, a Highly Selective Aurora-A Kinase Inhibitor, Shows Antitumor Activity Alone and in Combination with Docetaxel

Author

Shimomura, Toshiyasu, primary, Hasako, Shinichi, primary, Nakatsuru, Yoko, primary, Mita, Takashi, primary, Ichikawa, Koji, primary, Kodera, Tsutomu, primary, Sakai, Takumi, primary, Nambu, Tadahiro, primary, Miyamoto, Mayu, primary, Takahashi, Ikuko, primary, Miki, Satomi, primary, Kawanishi, Nobuhiko, primary, Ohkubo, Mitsuru, primary, Kotani, Hidehito, primary, and Iwasawa, Yoshikazu, primary

Published
2023
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15. Data from MK-5108, a Highly Selective Aurora-A Kinase Inhibitor, Shows Antitumor Activity Alone and in Combination with Docetaxel

Author

Shimomura, Toshiyasu, primary, Hasako, Shinichi, primary, Nakatsuru, Yoko, primary, Mita, Takashi, primary, Ichikawa, Koji, primary, Kodera, Tsutomu, primary, Sakai, Takumi, primary, Nambu, Tadahiro, primary, Miyamoto, Mayu, primary, Takahashi, Ikuko, primary, Miki, Satomi, primary, Kawanishi, Nobuhiko, primary, Ohkubo, Mitsuru, primary, Kotani, Hidehito, primary, and Iwasawa, Yoshikazu, primary

Published
2023
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16. Supplementary Table 1 from MK-5108, a Highly Selective Aurora-A Kinase Inhibitor, Shows Antitumor Activity Alone and in Combination with Docetaxel

Author

Shimomura, Toshiyasu, primary, Hasako, Shinichi, primary, Nakatsuru, Yoko, primary, Mita, Takashi, primary, Ichikawa, Koji, primary, Kodera, Tsutomu, primary, Sakai, Takumi, primary, Nambu, Tadahiro, primary, Miyamoto, Mayu, primary, Takahashi, Ikuko, primary, Miki, Satomi, primary, Kawanishi, Nobuhiko, primary, Ohkubo, Mitsuru, primary, Kotani, Hidehito, primary, and Iwasawa, Yoshikazu, primary

Published
2023
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17. Supplementary Figure 2 from MK-5108, a Highly Selective Aurora-A Kinase Inhibitor, Shows Antitumor Activity Alone and in Combination with Docetaxel

Author

Shimomura, Toshiyasu, primary, Hasako, Shinichi, primary, Nakatsuru, Yoko, primary, Mita, Takashi, primary, Ichikawa, Koji, primary, Kodera, Tsutomu, primary, Sakai, Takumi, primary, Nambu, Tadahiro, primary, Miyamoto, Mayu, primary, Takahashi, Ikuko, primary, Miki, Satomi, primary, Kawanishi, Nobuhiko, primary, Ohkubo, Mitsuru, primary, Kotani, Hidehito, primary, and Iwasawa, Yoshikazu, primary

Published
2023
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22. Correction to: A placebo‑controlled, double‑blind, randomized study of recombinant thrombomodulin (ART‑123) to prevent oxaliplatin‑induced peripheral neuropathy

Author

Kotaka, Masahito, primary, Saito, Yoji, additional, Kato, Takeshi, additional, Satake, Hironaga, additional, Makiyama, Akitaka, additional, Tsuji, Yasushi, additional, Shinozaki, Katsunori, additional, Fujiwara, Toshiyoshi, additional, Mizushima, Tsunekazu, additional, Harihara, Yasushi, additional, Nagata, Naoki, additional, Kurihara, Naoto, additional, Ando, Masahiko, additional, Kusakawa, Genichi, additional, Sakai, Takumi, additional, Uchida, Yugo, additional, Takamoto, Mikihiro, additional, Kimoto, Saki, additional, and Hyodo, Ichinosuke, additional

Published
2020
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27. Plasma from Patients Undergoing Liver Transplantation Is Resistant to Anticoagulant Activity of Soluble Thrombomodulin (ART-123)

Author

Burlage, Laura C, Bos, Sarah, Adelmeijer, Jelle, Sakai, Takumi, Porte, Robert J, Lisman, Ton, and Groningen Institute for Organ Transplantation (GIOT)

Abstract

BACKGROUND: Recombinant soluble human thrombomodulin (ART-123) is an anticoagulant and anti-inflammatory agent clinically used for treatment of disseminated intravascular coagulation. Preclinical studies have shown that ART-123 reduces hepatic ischemia/reperfusion. Although ART-123 may therefore have clinical benefit in orthotopic liver transplantation the substantial alterations in the hemostatic system may complicate its use in this setting. OBJECTIVE: Here we studied the in vitro effect of ART-123 on coagulation of patients with end-stage liver disease undergoing liver transplantation. PATIENTS/METHODS: Ten patients with end-stage liver disease undergoing liver transplantation were included in this study. Plasma samples of 10 healthy individuals were included to establish reference values. Different concentrations of ART-123 were added to plasma samples and peak thrombin generation and clot lysis times were determined. RESULTS: In patient samples, plasma was profoundly resistant to the anticoagulant action of ART-123, as reflected by significantly higher IC50 values of peak thrombin generation compared to controls. This might be partially explained by low levels of protein C, protein S and elevated levels of factor VIII during transplantation. Intraoperative levels of thrombin activatable fibrinolysis inhibitor (TAFI) were significantly lower, compared to controls. However, ART-123-dependent prolongation of clot lysis times was not significantly different from healthy controls. CONCLUSION: This study suggests that ART-123 is unlikely to provoke bleeding in patients undergoing liver transplantation as proposed clinical dosages have a virtually absent anticoagulant effect in these patients. Clinical studies are required to confirm safety of ART-123 and efficacy on alleviating I/R injury during liver transplantation. This article is protected by copyright. All rights reserved.

Published
2019

28. Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial

Author

Vincent, Jean-Louis, Francois, Bruno, Zabolotskikh, Igor, Daga, Mradul Kumar, Lascarrou, Jean-Baptiste, Kirov, Mikhail Y., Pettila, Ville, Wittebole, Xavier, Meziani, Ferhat, Mercier, Emmanuelle, Lobo, Suzana M., Barie, Philip S., Crowther, Mark, Esmon, Charles T., Fareed, Jawed, Gando, Satoshi, Gorelick, Kenneth J., Levi, Marcel, Mira, Jean-Paul, Opal, Steven M., Parrillo, Joseph, Russell, James A., Saito, Hidehiko, Tsuruta, Kazuhisa, Sakai, Takumi, Fineberg, David, Bertuzzi, Romina, Bellomo, Rinaldo, Chapman, Marianne, Ernest, David, Fletcher, Jason, French, Craig, Gowardman, John, Shehabi, Yahya, Venkatesh, Bala, Walsham, James, Vij, Sanjiv, Chochrad, Didier, Creteur, Jacques, Devriendt, Jacques, Dive, Alain-Michel, Dugernier, Thierry, Foret, Frederic, Hoste, Eric, Jorens, Philippe, Simon, Marc, Spapen, Herbert, Dias, Fernando, Freire, Antonio, Lobo, Suzana Margarth, Simeonov, Georgi, Stefanov, Chavdar, Aslanian, Pierre, Berthiaume, Luc, Martin, Claudio, Chittock, Dean, Dhar, Anil, Doig, Christopher, Jones, Gwynne, Hall, Richard, Boyd, John, Shin, Phil, Wood, Gordon, Zarychanski, Ryan, Quinteros, Guillermo Agamenon, Gasparovic, Vladimir, Husedzinovic, Ino, Balik, Martin, Burget, Ivo, Dlouhy, Pavel, Pachl, Jan, Karlsson, Sari, Laru-Sompa, Raili, Parviainen, Ilkka, Ruokone, Esko, Skrifvars, Markus, Bohe, Julien, Dellamonica, Jean, Duguet, Alexandre, Durand-Gasselin, Jacques, Fiancette, Maud, Joannes-Boyau, Olivier, Lefrant, Jean-Yves, Mercat, Alain, Nseir, Saad, Quenot, Jean-Pierre, Reignier, Jean, Schwebel, Carole, Marx, Gernot, Zacharowski, Kai, Armaganidis, Apostolos, Komnos, Apostolos, Fejer, Csaba, Appajigol, Jayaprakash, Behera, Sarat Kumar, ChandraShekhar, Shivprasad, Chowdhury, Sanmay, D'costa, Pradeep Micheal, Gupta, Hari Shankar Shivkumar, Iyer, Shivakumar, Khan, Zafer A., Mehta, Minesh, Murthy, Sudharshan, Sahu, Sambit, Tewari, Reshma, Bar-Lavie, Yaron, Bregman, Gennady, Cohen, Jonathan, Eden, Arie, Einav-Bromiker, Sharon, Jakobson, Daniel, Nimrod, Adi, Beishuizen, Albertus, Gerritsen, Richard, Pickkers, Peter, Rozendaal, Wim, Schoonderbeek, F. J., Spoelstra-de Man, Angelique, van Zanten, Arthur R. H., Zijlstra, Jan G., Freebairn, Ross, Henderson, Seton, McArthur, Colin, Young, Paul, Mayorga, Manuel Jesus, Agafina, Alina S., Bubnova, Natalia, Gritsan, Alexey, Kameneva, Evgenia, Katasonov, Sergey P., Khasanova, Nina M., Kruberg, Lilly, Kulabukhov, Vladimir V., Lebedinskii, Konstantin, Spesivtsev, Yuri A., Rankovic, Zarko, Hong, Sang Bum, Kim, Min-Ja, Suh, Gee Young, Yoo, Chul-Gyu, Raventos, Antonio Artigas, Ferrer, Ricard, Vazquez, Rita Galeiras, Hernandez, Marianela, Piacentini, Enrique, Rodriguez Oviedo, Alejandro Hugo, Garcia, Miguel Sanchez, Chan, Ming-Cheng, Cheng, Kuo-Chen, Yu, Chong-Jen, Eddleston, Jane, Smith, Fang Gao, MacNaughton, Peter, Welters, Ingeborg, Allen, Karen, Bochicchio, Grant, Carlson, Richard, Eaton, Stephanie, Fink, Ryan, Gianatiempo, Carmine, Kapoor, Rajat, Kinasewitz, Gary, Koura, Firas, Krell, Kenneth, Martin, Niels, Nepal, Santosh, Pastores, Stephen M., Peltan, Ithan, Pullman, John, Seibert, Allan, Smith, Jason, Tennenberg, Steven, Wilhelm, Andrew, Zeno, Brian, Allton, Pam, Carruthers, David, Matsuki, Osamu, Kayanoki, Toshihiko, UCL - SSS/IREC/MEDA - Pôle de médecine aiguë, UCL - (MGD) Services des soins intensifs, Intensive care medicine, ACS - Atherosclerosis & ischemic syndromes, ACS - Diabetes & metabolism, UCL - (SLuc) Service de soins intensifs, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), and SCARLET Trial Grp

Subjects
Male, medicine.medical_specialty, Thrombomodulin, COAGULATION, PROTEIN, Placebo, 01 natural sciences, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Intensive care, Cause of Death, Sepsis, medicine, Clinical endpoint, Coagulopathy, Humans, 030212 general & internal medicine, International Normalized Ratio, Treatment Failure, 0101 mathematics, Infusions, Intravenous, Original Investigation, Aged, business.industry, Mortality rate, 010102 general mathematics, Anticoagulants, General Medicine, Disseminated Intravascular Coagulation, Blood Coagulation Disorders, Middle Aged, medicine.disease, Recombinant Proteins, 3. Good health, Injections, Intravenous, Female, Human medicine, business, Packed red blood cells
Abstract

IMPORTANCE Previous research suggested that soluble human recombinant thrombomodulin may reduce mortality among patients with sepsis-associated coagulopathy.OBJECTIVE To determine the effect of human recombinant thrombomodulin vs placebo on 28-day all-cause mortality among patients with sepsis-associated coagulopathy.DESIGN, SETTING, AND PARTICIPANTS The SCARLET trial was a randomized, double-blind, placebo-controlled, multinational, multicenter phase 3 study conducted in intensive care units at 159 sites in 26 countries. All adult patients admitted to one of the participating intensive care units between October 2012 and March 2018 with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure, defined as an international normalized ratio greater than 1.40 without other known etiology and a platelet count in the range of 30 to 150 x 10(9)/L or a greater than 30% decrease in platelet count within 24 hours, were considered for inclusion. The final date of follow-up was February 28, 2019.INTERVENTIONS Patients with sepsis-associated coagulopathy were randomized and treated with an intravenous bolus or a 15-minute infusion of thrombomodulin (0.06mg/kg/d [maximum, 6mg/d]; n=-395) or matching placebo (n=-405) once daily for 6 days.MAIN OUTCOME AND MEASURES The primary end pointwas 28-day all-cause mortality.RESULTS Among 816 randomized patients, 800 (mean age, 60.7 years; 437 [54.6%] men) completed the study and were included in the full analysis set. In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P=-.32). The absolute risk difference was 2.55%(95% CI, -3.68% to 8.77%). The incidence of serious major bleeding adverse events (defined as any intracranial hemorrhage; life-threatening bleeding; or bleeding event classified as serious by the investigator, with administration of at least 1440mL [typically 6 units] of packed red blood cells over 2 consecutive days) was 23 of 396 patients (5.8%) in the thrombomodulin group and 16 of 404 (4.0%) in the placebo group.CONCLUSIONS AND RELEVANCE Among patients with sepsis-associated coagulopathy, administration of a human recombinant thrombomodulin, compared with placebo, did not significantly reduce 28-day all-cause mortality.TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01598831

Published
2019
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44. MK-1775, a small molecule Wee1 inhibitor, enhances anti-tumor efficacy of various DNA-damaging agents, including 5-fluorouracil

Author

Hirai, Hiroshi, primary, Arai, Tsuyoshi, additional, Okada, Megumu, additional, Nishibata, Toshihide, additional, Kobayashi, Makiko, additional, Sakai, Naoko, additional, Imagaki, Kazuhide, additional, Ohtani, Junko, additional, Sakai, Takumi, additional, Yoshizumi, Takashi, additional, Mizuarai, Shinji, additional, Iwasawa, Yoshikazu, additional, and Kotani, Hidehito, additional

Published
2010
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45. MK-5108, a Highly Selective Aurora-A Kinase Inhibitor, Shows Antitumor Activity Alone and in Combination with Docetaxel

Author

Shimomura, Toshiyasu, primary, Hasako, Shinichi, additional, Nakatsuru, Yoko, additional, Mita, Takashi, additional, Ichikawa, Koji, additional, Kodera, Tsutomu, additional, Sakai, Takumi, additional, Nambu, Tadahiro, additional, Miyamoto, Mayu, additional, Takahashi, Ikuko, additional, Miki, Satomi, additional, Kawanishi, Nobuhiko, additional, Ohkubo, Mitsuru, additional, Kotani, Hidehito, additional, and Iwasawa, Yoshikazu, additional

Published
2010
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46. Small-molecule inhibition of Wee1 kinase by MK-1775 selectively sensitizes p53-deficient tumor cells to DNA-damaging agents

Author

Hirai, Hiroshi, primary, Iwasawa, Yoshikazu, additional, Okada, Megumu, additional, Arai, Tsuyoshi, additional, Nishibata, Toshihide, additional, Kobayashi, Makiko, additional, Kimura, Toshifumi, additional, Kaneko, Naoki, additional, Ohtani, Junko, additional, Yamanaka, Kazunori, additional, Itadani, Hiraku, additional, Takahashi-Suzuki, Ikuko, additional, Fukasawa, Kazuhiro, additional, Oki, Hiroko, additional, Nambu, Tadahiro, additional, Jiang, Jian, additional, Sakai, Takumi, additional, Arakawa, Hiroharu, additional, Sakamoto, Toshihiro, additional, Sagara, Takeshi, additional, Yoshizumi, Takashi, additional, Mizuarai, Shinji, additional, and Kotani, Hidehito, additional

Published
2009
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