Prospective Registry of Rivaroxaban Management of Cancer-Associated Venous Throboembolism (PRIMECAST) Study.

Autor:	Tamura Y; Department of Cardiology, International University of Health and Welfare School of Medicine, Mita Hospital Tokyo Japan.; International University of Health and Welfare School of Medicine Narita Japan., Iwasa T; Department of General Internal Medicine, National Cancer Center Hospital Tokyo Japan., Kumamaru H; Department of Healthcare Quality Assessment, The University of Tokyo Tokyo Japan., Miyata H; Department of Health Policy and Management, Keio University School of Medicine Tokyo Japan., Mukai M; Osaka Prefectural Hospital Organization, Osaka International Cancer Institute, Department of Medical Checkup Osaka Japan., Shigematsu K; Department of Vascular Surgery, International University of Health and Welfare School of Medicine, Mita Hospital Tokyo Japan., Shoji M; Department of General Internal Medicine, National Cancer Center Hospital Tokyo Japan., Tanabe N; Pulmonary Hypertension Center, Chibaken Saiseikai Narashino Hospital Narashino Japan., Yamada N; Department of Cardiology, Kuwana City Medical Center Kuwana Japan., Yasuda C; Japanese Foundation for Cancer Research Tokyo Japan., Miyata T; International University of Health and Welfare School of Medicine Narita Japan.; Vascular Center Sanno Medical Center Tokyo Japan.
Jazyk:	angličtina
Zdroj:	Circulation reports [Circ Rep] 2019 Nov 01; Vol. 1 (11), pp. 534-537. Date of Electronic Publication: 2019 Nov 01.
DOI:	10.1253/circrep.CR-19-0078
Abstrakt:	Background: The incidence of thromboembolism in patients with cancer is approximately 11%, and the risk of thrombosis in patients with malignant tumors is 6-fold higher than that in healthy persons. Thrombosis not only disrupts the treatment of cancer but also induces deterioration of quality of life (QOL). Knowledge about thrombus treatment is limited, and evidence is scarce. Clarification of the status and safety of venous thromboembolism (VTE) treatment in patients with cancer will contribute to active intervention and improvement of prognosis and QOL. In this study, the therapeutic effects of a non-vitamin K antagonist oral anticoagulant for VTE and the prognosis of cancer after treatment will be examined to establish a therapeutic method for VTE in patients with cancer. Methods and Results: A multicenter, non-interventional, observational study will be conducted in patients with cancer who developed VTE and underwent anticoagulant therapy with rivaroxaban (group A) or warfarin (group B) for 24 weeks. The primary endpoint will be the recurrence/aggravation of symptomatic VTE or occurrence/aggravation of deep vein thrombosis. Registration of 500 patients is needed in order to calculate the 95% confidence interval of the event rate at ±1% precision. Conclusions: The investigation period will run from January 2019 to December 2023 with ongoing selection of patients. Trial registration: no. 5-18-32 (approved 1 August 2018). Competing Interests: Y.T. received a research grant from Bayer Yakuhin, Daiichi Sankyo and lecture fees from Bayer Yakuhin, Pfizer and Daiichi-Sankyo; M.M. received lecture fees from Daiichi Sankyo, Bayer Yakuhin and Pfizer; N.Y. received lecture fees from Bayer, Daiichi-Sankyo, Pfizer and Bristol-Myers Squibb; N.T. received lecture fees from Bayer Yakuhin, and Daiichi-Sankyo; C.Y. received lecture fees from Bayer Yakuhin, Pfizer and Daiichi-Sankyo; T.I. received lecture fees from Daiichi Sankyo, Bayer Yakuhin; K.S., H.K., H.M. and M.S. declare no conflicts of interest; T.M. received a research grant from Bayer Yakuhin, Daiichi-Sankyo, and received lecture fees from Bayer Yakuhin, Bristol-Myers Squibb, and Daiichi-Sankyo. This study will be conducted using the fund provided by Bayer Yakuhin, within the range of the health insurance treatment and based on the agreement on the investigator-initiated study between International University for Health and Welfare and the company. The company will have no part in the study administration including the study conduct, data control, statistical analysis or publication of results. With regard to conflict of interest between the investigators and the company, the provisions set at each study site will be followed taking care not to deviate from them. (Copyright © 2019, THE JAPANESE CIRCULATION SOCIETY.)
Databáze:	MEDLINE
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