Clot regression effects of rivaroxaban in the treatment of venous thromboembolism in patients with cancer (CRERIT-VTE cancer): study protocol
| Autor: | Takanori Kawasaki, Isao Yokota, Takashi Okada, Kojiro Imai, Hiroshi Fujita, Naohiko Nakanishi, Ayumu Yamada, Takahisa Sawada, Satoaki Matoba, Shigeki Takai |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
medicine.medical_specialty Deep vein venous thromboembolism Cardiovascular Medicine 03 medical and health sciences Young Adult 0302 clinical medicine Rivaroxaban Internal medicine Neoplasms medicine Protocol Humans cancer 030212 general & internal medicine cardiovascular diseases Thrombus Aged business.industry Standard treatment Cancer Thrombosis General Medicine Middle Aged medicine.disease Institutional review board medicine.anatomical_structure Complication business 030217 neurology & neurosurgery medicine.drug Factor Xa Inhibitors |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | IntroductionAnticoagulant therapy in patients with cancer with venous thromboembolism (VTE) increases the risk of both VTE recurrence and haemorrhagic complication. Direct oral anticoagulants (DOACs) have been shown to be effective in preventing VTE recurrence, and comparable to conventional therapy in preventing VTE recurrence in patients with advanced cancer. Rivaroxaban is a DOAC that causes thrombus regression, possibly through a profibrinolytic effect. Thrombus regression with initial treatment is essential for VTE patients. However, the thrombolytic effect of DOAC for VTE patients with cancer has not been fully examined. Therefore, in this study, we investigate the thrombolytic effect of rivaroxaban in patients with cancer who develop VTE.Methods and analysisThis study is a single-arm, open-label, prospective interventional study. Forty patients aged from 20 to 75 years old at the time of consent who have been diagnosed with acute VTE and have active cancer are included. Patients are excluded if they have received thrombolytic therapy, have creatinine clearance of less than 30 mL/min, have expected a life expectancy of less than 6 months or have deep vein thrombosis limited to the distal lower leg. Eligible patients receive standard treatment with rivaroxaban (15 mg two times daily for 3 weeks, followed by 15 mg QD). The primary study endpoint is clot regression ratio as evaluated by contrast-enhanced CT imaging. CT imaging is obtained at baseline, 21±4 and 90±14 days after the start of rivaroxaban treatment. Secondary endpoints are the recurrence of VTE and haemorrhagic complications.Ethics and disseminationThis study was approved by the institutional review board of the Kyoto Prefectural University of Medicine. Study results will be disseminated through peer-reviewed journals.Trial registration numberUMIN000027793 |
| Databáze: | OpenAIRE |
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