The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 204
- 主要终点
- occurrence of venous thrombosis
研究概览
简要总结
Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with a history of allergies to rivaroxaban;
- •History of recent major or clinically relevant bleeding within the previous 4 weeks.
- •Patients with bleeding risks: thrombocytopenia (platelet count < 50*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke; Inadequate renal function; creatinine clearance < 30 ml/min；
- •Inadequate hepatic function: aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN
- •Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments.
- •Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk.
- •Patients who have had anticoagulant drugs for any other reason.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
rivaroxaban
oral Rivaroxaban 10mg per day for 90days
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
occurrence of venous thrombosis
时间窗: From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months
detect the occurrence of venous thrombosis with ultrasound, venography if necessary.
occurrence of a major bleeding event.
时间窗: From date of randomization until the date of occurrence of a major bleeding event or date of death from any cause, whichever came first, assessed up to 6 months
define occurrence of major-bleeding event with ISTH standard
occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event
时间窗: From date of randomization until the date of occurrence of events or date of death from any cause, whichever came first, assessed up to 6 months
define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0
次要结局
未报告次要终点
研究者
tingliu
Principal Investigator
LiuZhou People's Hospital