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
NCT ID: NCT07142655
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1500 participants
OBSERVATIONAL
2025-08-12
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Exposure
Patients who were prescribed rivaroxaban 2.5 mg during the enrollment period
No interventions assigned to this group
Reference
Patients who were not prescribed rivaroxaban 2.5mg during the enrollment period and were matched with patients in the exposure group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Index date before the start date of the enrollment period
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Medical Data Vision Co., Ltd
Tokyo, , Japan
Countries
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Related Links
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Other Identifiers
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22340
Identifier Type: -
Identifier Source: org_study_id
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