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临床试验/NCT03965741
NCT03965741已完成不适用

Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE

Bayer1 个研究点 分布在 1 个国家目标入组 97,765 人开始时间: 2019年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
97,765
试验地点
1
主要终点
Time between a first cancer-related and a recurrent VTE event

研究概览

简要总结

Patients with cancer are at a significantly increased risk of experiencing a venous thromboembolism (VTE). VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism) and is a leading cause of condition of being diseased and death among cancer patients. The goal of the study is to gather information how often venous thromboembolism (VTE) occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • Initially all patients newly diagnosed with PCa between 2007-2016 with at least one year before the end of follow up date (31 December 2017) will be included. From this population, a sub-population of PCa patients with a first cancer-related VTE event will be selected.

排除标准

  • 未提供

研究组 & 干预措施

Men with Prostate Cancer (PCa)

干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)

Men with Prostate Cancer (PCa)

干预措施: Apixaban(Eliquis) (Drug)

Men with Prostate Cancer (PCa)

干预措施: Pradaxa (Dabigatran etexilate) (Drug)

结局指标

主要结局

Time between a first cancer-related and a recurrent VTE event

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa and a first cancer-related VTE event

Subject's socio-demographic at the date of an incident PCa diagnosis

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa

Incidence rate of cancer-related VTE

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa

Duration of treatment

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa and a first cancer-related VTE event; To characterize the long-term anticoagulation treatment

Subject's clinical characteristics at the date of an incident PCa diagnosis

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa

Cancer therapies in PCa at the initial time after diagnosis

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa

Choice of drug

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa and a first cancer-related VTE event; To characterize the long-term anticoagulation treatment

Occurrence of recurrent VTE events

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa and a first cancer-related VTE event; By long-term anticoagulation treatment (LMWH (Low molecular weight heparin), VKA (Vitamin K anticoagulants) or NOAC (Non-vitamin K oral anticoagulation)) and its estimated duration (up 3 months, 3-6 months, more than 6 months)

Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment

时间窗: Retrospective analysis between 2007 and 2016

Among men with PCa and a first cancer-related VTE event

次要结局

  • Subject's socio-demographic at the time of inclusion into the database(Retrospective analysis between 2007 and 2016)
  • Subject's clinical characteristics at the time of inclusion into the database(Retrospective analysis between 2007 and 2016)
  • Incidence rate of VTE events(Retrospective analysis between 2007 and 2016)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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