Post-Marketing Database Study for Rivaroxaban in Patients With PAD After Lower Limb Revascularization.

Bayer1 个研究点分布在 1 个国家目标入组 1,500 人开始时间: 2025年8月12日最近更新: 2026年8月6日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 1,500
试验地点: 1
主要终点: Intracranial bleeding

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an observational study in which data already collected from people with peripheral arterial diseases (PAD) who had a surgery to improve blood flow to their legs are studied.

The study is conducted to check the safety of rivaroxaban after it is approved and available in Japan.

In observational studies, only observations are made without participants receiving any advice or changes to healthcare.

PAD is a condition where blood flow is reduced in the arteries of the legs and arms. This can cause pain, numbness, or weakness in the legs, and increases the risk of heart attack and other heart-related problems. People with PAD may undergo surgery to improve blood flow to their legs, in which doctors use a thin tube to open a narrow or blocked blood vessel in the legs.

The study drug, rivaroxaban, is already approved for doctors to prescribe to people with PAD. It works by blocking a protein that causes blood clots, helping to prevent clot formation and improving blood flow.

The participants in this study are already receiving treatment with rivaroxaban 2.5 milligrams (mg) as part of their regular care from their doctors.

There have been studies in which researchers studied the effect and safety of rivaroxaban in participants with PAD who had a surgery to improve blood flow to their legs. However, these studies included only a small number of Japanese participants. In this study, researchers will specifically gather data from Japanese participants to further understand the safety of rivaroxaban.

The main purpose of the study is to learn more about the safety of rivaroxaban 2.5 mg in Japanese participants with PAD who had a surgery to improve blood flow to their legs.

To do this, researchers will collect information about:

any bleeding event participants have had during their treatment with rivaroxaban
the participants who died due to the heart and blood flow related problems while receiving rivaroxaban, compared to those who did not receive it

The data will come from electronic healthcare records for people in Japan who had a surgery to improve blood flow to their legs and were diagnosed with PAD between October 2021 to September 2025.

In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

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: 否

入选标准

•Diagnosed with PAD in or before the month following the index date
•Lower limb revascularization was performed in or before the month of PAD diagnosis
•Age 18 years or older as of the index date

排除标准

•Lower limb revascularization performed in the same month or before the month of PAD diagnosis was performed after the index date
•Index date before the start date of the enrollment period

研究组 & 干预措施

Exposure

Patients who were prescribed rivaroxaban 2.5 mg during the enrollment period

Reference

Patients who were not prescribed rivaroxaban 2.5mg during the enrollment period and were matched with patients in the exposure group