An Observational Study to Learn More About the Safety of Rivaroxaban in Participants With Peripheral Arterial Disease Who Had Surgery to Improve Blood Flow to Their Legs

Bayer

Status

Active, not recruiting

Conditions

Peripheral Arterial Disease (PAD)

Study type

Observational

Funder types

Industry

Identifiers

NCT07142655

22340

Details and patient eligibility

About

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.

Enrollment

1,500 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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