Peripheral Arterial Disease (PAD)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
An observational study of Peripheral Arterial Disease (PAD), run by Bayer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- How many people
- 1,500 participants
- Where
- 1 siteJapan
- Study dates
- 12 Aug 2025to 9 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is patients with PAD after lower limb revascularization.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Post-Marketing Database Study for Rivaroxaban in Patients With PAD After Lower Limb Revascularization.
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.
Read more
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)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
Secondary outcomes (2)
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
Measured: 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
Measured: Retrospective analysis from 01-OCT-2021 to 30-SEP-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start12 Aug 2025
- Primary completion9 Mar 2026
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142655
- Sponsor's protocol ID
- 22340
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Database Study for Rivaroxaban in Patients With PAD After Lower Limb Revascularization.
- ClinicalTrials.gov ID
- NCT07142655
- Acronym / sponsor ID
- 22340
- Conditions
- Peripheral Arterial Disease (PAD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with PAD after lower limb revascularization.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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.
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
2 secondary outcomes
All cause death
Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025
Re-performing lower limb revascularization
Time frame: Retrospective analysis from 01-OCT-2021 to 30-SEP-2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease (PAD), run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhage requiring for blood transfusion (time frame: Retrospective analysis from 01-OCT-2021 to 30-SEPT-2025). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.