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临床试验/NCT05150938
NCT05150938已完成不适用

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)

Bayer1 个研究点 分布在 1 个国家目标入组 5,737 人开始时间: 2022年3月18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
5,737
试验地点
1
主要终点
All-cause death

研究概览

简要总结

This is an observational study in which patient data from the past on venous thromboembolism (VTE) in patients with cancer is studied.

VTE is a condition in which a patient has problems due to the formation of blood clots in the veins. Blood clots can reduce the flow of blood to vital organs such as the heart and lungs, which can lead to them becoming damaged. VTE can also be "recurrent". This means that the blood clots have returned after treatment. People who have cancer have an increased risk of developing VTE.

Three main types of anticoagulation treatments ("blood thinners") have been available for patients with cancer who also have VTE

  • Low molecular weight heparins (LMWHs)
  • Vitamin K antagonists (VKAs)
  • Non-vitamin K antagonist oral anticoagulants (NOACs) The treatment rivaroxaban belongs to the NOACs.

Compared to other treatments available to patients who have cancer and VTE, NOACs may cause fewer medical problems and can be easier for patients to take correctly.

In this study, the researchers will collect data about:

  • the type of VTE treatments given and for how long the treatments are taken
  • the risk of blood clots returning in the veins after treatment, any events of major bleeding, and the number of deaths in patients with cancer who do not have a high risk of bleeding

The researchers will compare this information in the patients

  • who received rivaroxaban to the patients who received LMWHs
  • who received NOACs to the patients who received LMWHs.

There will be no required visits with a study doctor or required tests in this study. The researchers will look at the health information from adult patients in Sweden who were diagnosed with cancer between 2013 and 2019 and also have VTE. The researchers will collect this information from Swedish health registers including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A resident in Sweden of 18+ years of age
  • A Swedish Person Identification Number
  • A diagnosis of cancer ((ICD10 = C00-C97) in the Swedish Cancer registry during 2013-2019 and a diagnosis of VTE subsequent to the cancer diagnosis.

排除标准

  • A diagnosis of atrial fibrillation, total hip or knee replacement or acute coronary syndrome (for evaluation of treatment patterns) before the date of VTE diagnosis
  • A dispensed prescription for any oral anticoagulant (OAC) before the date of VTE diagnosis
  • A cancer diagnosis associated with high bleeding risk, including upper gastrointestinal cancer, malignant immunoproliferative diseases and leukemia

研究组 & 干预措施

Cancer patients with VTE

Cancer patients who received anticoagulation treatment.

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

Cancer patients with VTE

Cancer patients who received anticoagulation treatment.

干预措施: Low molecular weight heparin (LMWH) (Drug)

Cancer patients with VTE

Cancer patients who received anticoagulation treatment.

干预措施: vitamin K antagonist (VKA) (Drug)

Cancer patients with VTE

Cancer patients who received anticoagulation treatment.

干预措施: other NOACs (Drug)

结局指标

主要结局

All-cause death

时间窗: Retrospective data analysis from 2013 to 2020

Choice of anticoagulation treatments for VTE

时间窗: Retrospective data analysis from 2013 to 2020

Recurrence of VTE

时间窗: Retrospective data analysis from 2013 to 2020

Major bleedings

时间窗: Retrospective data analysis from 2013 to 2020

All-cause death with different treatment types of LMWH, VKA and NOAC

时间窗: Retrospective data analysis from 2013 to 2020

Duration of anticoagulation treatments for VTE

时间窗: Retrospective data analysis from 2013 to 2020

Major bleedings with different treatment types of LMWH, VKA and NOAC

时间窗: Retrospective data analysis from 2013 to 2020

Recurrence of VTE with different treatment types of LMWH, VKA and NOAC

时间窗: Retrospective data analysis from 2013 to 2020

次要结局

未报告次要终点

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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