Skip to main content
OpenTrials
Completed

NCT Number: NCT07142655

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Data Vision Co., Ltd

Tokyo, 101-0053, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hemorrhage requiring for blood transfusion

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    If all of the following criteria are met:

    • A transfusion with a blood volume equivalent to > 800 mL is recorded after the index date
    • No surgery other than endoscopic hemostasis surgery is performed on the day before or on the day of the transfusion
    • No anticoagulants is prescribed on the day following the transfusion

  2. Intracranial bleeding

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    If all of the following criteria are met:

    • An Magnetic Resonance Imaging (MRI) or a Computed Tomography (CT) examination is performed at or after the index date
    • A diagnosis for any intracranial bleeding is recorded in the same month of the MRI or CT examination
    • A rehabilitation for stroke or a death is recorded within 30 days after the MRI or CT examination

  3. Intraocular bleeding

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    If all of the following criteria are met:

    • An ophthalmologic examination is performed after the index date
    • A diagnosis for any intraocular bleeding is recorded in the same month of the ophtalmologic examination

  4. Upper gastrointestinal bleeding

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    If all of the following criteria are met:

    • An examination related to an upper gastrointestinal bleeding is performed after the index date
    • A diagnosis for any upper gastrointestinal bleeding is recorded in the same month of examination
    • No anticoagulants is prescribed on the day following the examination

  5. Lower gastrointestinal bleeding

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    If all of the following criteria are met:

    • An examination related to a lower gastrointestinal bleeding is performed after the index date
    • A diagnosis for any lower gastrointestinal bleeding is recorded in the same month of examination
    • No anticoagulants is prescribed on the day following the examination

  6. Sudden cardiac death

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    A diagnosis for sudden cardiac death is recorded after the index date.

  7. Acute coronary syndrome and death

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    If all of the following criteria are met:

    • A diagnosis for Acute coronary syndrome is recorded after the index date
    • At the date of sudden cardiac death, Peripheral Component Interconnect (PCI) is recorded
    • Death within 30 days of sudden cardiac death

Secondary outcomes

  1. All cause death

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

    Date of death. A diagnosis for death related disease or death is recorded after the index date. The index date is defined as:

    • The date of the first prescription of rivaroxaban 2.5mg during the enrollment period (from 24-OCT-2022 to 30-SEP-2025), for patients included in the exposure group.
    • The earliest date of prescription of either aspirin or clopidogrel after the date of lower limb revascularization, for patients included in the reference group

  2. Re-performing lower limb revascularization

    Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEP-2025

    Date of lower limb revascularization. In case of multiple lower limb revascularizations, the earliest date after the index date will be used. The index date is defined as:

    • The date of the first prescription of rivaroxaban 2.5mg during the enrollment period (from 24-OCT-2022 to 30-SEP-2025), for patients included in the exposure group.
    • The earliest date of prescription of either aspirin or clopidogrel after the date of lower limb revascularization, for patients included in the reference group

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.