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

NCT07142655 | Completed

• 1 other identifier: 22340
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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.

  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

  Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

Secondary Outcomes (2)

• All cause death

  Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025

• Re-performing lower limb revascularization

  Retrospective analysis from 01-OCT-2021 to 30-SEP-2025

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is patients with PAD after lower limb revascularization.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Medical Data Vision Co., Ltd

Tokyo, 101-0053, Japan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: August 27, 2025
• Study Start: August 12, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)