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Peripheral Arterial Disease (PAD)

Bayer Identifier:
22340
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
1500
Trial Dates
August 2025 - September 2025
Phase
N/A
Could I Receive a placebo
N/A
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Primary Outcome

  • Hemorrhage requiring for blood transfusion
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
  • Intracranial bleeding
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
  • Intraocular bleeding
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
  • Upper gastrointestinal bleeding
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
  • Lower gastrointestinal bleeding
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
  • Sudden cardiac death
    A diagnosis for sudden cardiac death is recorded after the index date.
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
  • Acute coronary syndrome and death
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

Secondary Outcome

  • All cause death
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
  • Re-performing lower limb revascularization
    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
    date_rangeTime Frame:
    Retrospective analysis from 01-OCT-2021 to 30-SEP-2025

Trial design

Post-Marketing Database Study for rivaroxaban in patients with PAD after lower limb revascularization.
Trial Type
Observational
Intervention Type
N/A
Trial Purpose
Prevention
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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