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临床试验/NCT04724460
NCT04724460已完成4 期

Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients with Cancer

Takeshi Morimoto1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2021年2月18日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
179
试验地点
1
主要终点
VTE recurrence event Venous thromboembolism (VTE) recurrence event

研究概览

简要总结

The primary purpose of this study is to determine the optimal duration of anticoagulation therapy (6 months versus 18 months) with direct oral anticoagulant (DOAC) for cancer-associated low-risk pulmonary embolism patients. The major secondary purpose of this study is to investigate whether home treatment of cancer-associated low-risk pulmonary embolism patients with rivaroxaban is feasible, effective, and safe through an observational management study.

详细描述

Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating VTE, although data on low-risk PE, including incidental PE and asymptomatic PE has been quite limited. However, low-risk PE was reported to account for a large proportion of all the diagnoses of PE detected on computed tomography in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines weakly suggest the same approach for low-risk PE patients with cancer as other PE patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that low-risk patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, the investigators randomly assign low-risk PE patients with active cancer to receive either rivaroxaban for 6 months (short DOAC group) or rivaroxaban for 18 months (long DOAC group).

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with active cancer (solid and hematologic malignancies) presenting with objectively newly confirmed pulmonary embolism who are scheduled to be treated by anticoagulation therapy.
  • Patients with an simplified Pulmonary Embolism Severity Index (PESI) score of 1 or less

排除标准

  • Contraindicated patients for rivaroxaban (Clinically significant liver disease, Bacterial endocarditis, Active bleeding, Inadequate contraceptive measures if of childbearing potential, Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers or P-glycoprotein inhibitors or inducers)
  • Expected life expectancy <6 months
  • Patients who do not provide written informed consent
  • Patients who judged to be inappropriate for enrolment by the physician (including patients at a high risk of gastrointestinal or genitourinary bleeding)

研究组 & 干预措施

Long DOAC

Active Comparator

Administration of Rivaroxaban for 18 months

干预措施: Long DOAC (Drug)

Short DOAC

Active Comparator

Administration of Rivaroxaban for 6 months

干预措施: Short DOAC (Drug)

结局指标

主要结局

VTE recurrence event Venous thromboembolism (VTE) recurrence event

时间窗: 18 months

VTE recurrence event is defined as pulmonary embolism (PE) and/or deep vein thrombosis (DVT) by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy.

次要结局

  • Major bleeding event (ISTH criteria)(18 months)
  • PE-related death event(18 months)
  • A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria)(3 months)
  • Symptomatic VTE recurrence event(18 months)
  • Hospitalization for VTE recurrence or clinically relevant bleeding events(3 months)
  • Clinically relevant non-major (CRNM) bleeding(18 months)
  • Clinically relevant bleeding(18 months)
  • All-cause death(18 months)
  • Any adverse outcomes during invasive procedures(18 months)
  • Bleeding-related death event(18 months)

研究者

发起方
Takeshi Morimoto
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Takeshi Morimoto

Study Statistician

Kyoto University, Graduate School of Medicine

研究点 (1)

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