Peripheral Artery DiseasePADELTONCT04824729
A Study Related to the VOYAGER PAD Trial to Learn More About the Target Population for Xarelto in French Patients
An observational study of Peripheral Artery Disease, run by Bayer at 1 site in France.
Trial summary
This is a study to learn more about French patients who have peripheral artery disease (PAD) and who have had a revascularization procedure. With this procedure, doctors use surgery or a thin tube (called a catheter) to open a narrow or blocked blood vessel in the lower limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Lower limb revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 227,613 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2021to 7 Jan 2022
- 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
- Adult, Older adult
Study population: PAD revascularized population; Patients with lower-extremity PAD having undergone a lower limb revascularization during a hospital stay in France occurring between January 1, 2016 and ending by December 31, 2019 will be included into the study at the time of a lower limb revascularization hospital stay. VOYAGER PAD-like population: This population will be constituted to fit the VOYAGER PAD clinical trial population. It will be created using the VOYAGER PAD exclusion criteria.
Who may be able to join
- Patients with hospital stays identified through ICD-10 and surgical procedure (CCAM) codes:
- Patient with a lower-extremity PAD.
- Patient with a lower limb revascularization procedure.
Who cannot join
- None
- Patients presenting the following medical history at index date will be excluded from the VOYAGER PAD-like population.:
- Prior revascularization within 10 days of the qualifying lower limb revascularization
- ALI within 2 weeks prior to the qualifying lower limb revascularization
- Patients with major tissue loss (defined as significant ulceration/gangrene proximal to the metatarsal heads, i.e. heel or midfoot)
- Atrial fibrillation and flutter
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- Mechanical valve history
- History of hemorrhage
- Chronic hepatic failure (Any known hepatic disease associated with coagulopathy or bleeding risk)
- Gastrointestinal ulcer
- Oesophageal varices
- Dialysis
- Confirmed Acute Coronary Syndrome (ACS) within 30 days prior to lower limb revascularization
- Any history of intracranial hemorrhage, stroke, or transient ischemic attack (TIA)
- Known active malignancy, excluding local skin cancer (basal or squamous cell carcinoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Definition of the Target Population for Xarelto's New Indications in Connection With the VOYAGER PAD Study
This is a study to learn more about French patients who have peripheral artery disease (PAD) and who have had a revascularization procedure. With this procedure, doctors use surgery or a thin tube (called a catheter) to open a narrow or blocked blood vessel in the lower limbs.
In a previous Bayer trial called VOYAGER PAD, researchers studied Xarelto in participants with PAD who had recently had a revascularization procedure in their lower leg. The researchers studied how well Xarelto worked and how safe it was in these participants.
Read more
Based on the results of the VOYAGER PAD trial, the researchers in this study want to learn the number of patients with PAD who had a revascularization procedure in France from January 1st, 2016 to December 31st, 2019. This can help the researchers learn more about the target population (a specific group of people) who could potentially receive treatment with Xarelto.
Xarelto is available for doctors in France to prescribe to patients who have the following conditions:
- to reduce the risk of another heart attack or of dying from a disease related to the heart or the blood vessels in adults with acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) who have had an increase in certain cardiac blood tests
- to reduce the risk of getting blot clots (atherothrombotic events) in adults at a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms
- to prevent blood clots in the veins after a hip or knee replacement operation in adults
- to prevent blood clots in brain (stroke) and other blood vessels in the body in adults who have a form of irregular heart rhythm called non-valvular atrial fibrillation
- to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of the legs and/or lungs in adults
- to treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs in full-term newborn babies, infants and toddlers, children and adolescents below 18 years following an initial treatment of at least 5 days with injectable medicines used to treat blood clots
All the patients in this study will have PAD in their lower leg. They will all have had a revascularization procedure during a hospital stay in France between January 1st, 2016 and December 31st, 2019. The researchers will collect the patients' health data from the French National Health Insurance (NHI) hospital discharge database (PMSI). The researchers will look at the health data from all patients with PAD who had a revascularization procedure and also patients who could have joined the VOYAGER PAD trial. This group will not include any patients who have health conditions other than PAD.
The researchers will review each patient's medical records until December 31st, 2019 or earlier if the patient has died. The researchers will also look at any previous medical records from the date of each patient's revascularization procedure back to January 1st, 2014. The researchers will use these medical records to look for any health conditions other than PAD that the patients may have had before their revascularization procedure after January 1st 2016.
The main question the researchers want to answer in this study is: how many patients with PAD had a revascularization procedure between January 1st, 2016 and December 31st, 2019?
- Conditions
- Peripheral Artery Disease
- Being tested
- Lower limb revascularization
- 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.
Lower limb revascularizationProcedure or surgery
French population of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization.
Lower limb revascularizationProcedure or surgery
French population of patients matching the VOYAGER PAD exclusion criteria resembling a subgroup of the PAD revascularized population.
| Study group | Role | What they receive |
|---|---|---|
| French PAD revascularized population | Patients with lower-extremity peripheral artery disease (PAD) who have undergone lower limb revascularization (PAD revascularized population) in France from 2016 to 2019. Receives: Procedure: Lower limb revascularization | |
| French VOYAGER PAD-like population | VOYAGER PAD-like patients in France from 2016 to 2019.
This population will be constituted to fit the VOYAGER PAD clinical trial population. It will be created using the VOYAGER PAD exclusion criteria and resembles a subgroup of the PAD revascularized population. Receives: Procedure: Lower limb revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization
Retrospective data analysis carried out on the French National Health Insurance's (NHI) hospital discharge database (PMSI) on PAD revascularized population in France from 2016 to 2019.
Measured: 3 years
Secondary outcomes (5)
Number of patients with lower-extremity peripheral artery disease matching the VOYAGER PAD inclusion and exclusion criteria
Retrospective data analysis carried out on the French National Health Insurance's (NHI) hospital discharge database (PMSI) on VOYAGER PAD-like population in France from 2016 to 2019.
Measured: 3 years
Characteristics of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization
Retrospective data analysis carried out on the French National Health Insurance's (NHI) hospital discharge database (PMSI) on PAD revascularized population in France from 2016 to 2019.
Measured: 3 years
Characteristics of patients with lower-extremity peripheral artery disease matching the VOYAGER PAD inclusion and exclusion criteria
Retrospective data analysis carried out on the French National Health Insurance's (NHI) hospital discharge database (PMSI) on VOYAGER PAD-like population in France from 2016 to 2019.
Measured: 3 years
Risk of major thrombotic vascular events in patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization
Retrospective data analysis carried out on the French National Health Insurance's (NHI) hospital discharge database (PMSI) to evaluate the risk of major thrombotic vascular events (defined as Myocardial Infarction (MI), ischemic stroke, Acute Limb Ischemia (ALI), and major amputation of a vascular etiology) in patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization in France from 2016 to 2018.
Measured: 2 years
Risk of major thrombotic vascular events in patients matching the VOYAGER PAD inclusion and exclusion criteria
Retrospective data analysis carried out on the French National Health Insurance's (NHI) hospital discharge database (PMSI) to evaluate the risk of major thrombotic vascular events (defined as Myocardial Infarction (MI), ischemic stroke, Acute Limb Ischemia (ALI), and major amputation of a vascular etiology) on the VOYAGER PAD-like population in France from 2016 to 2018.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start24 Mar 2021
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- 227,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- External supplier: HEVA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824729
- Sponsor's protocol ID
- 21849
- Acronym
- PADELTO
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2021
- Last updated
- 25 Apr 2022
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of the Target Population for Xarelto's New Indications in Connection With the VOYAGER PAD Study
- ClinicalTrials.gov ID
- NCT04824729
- Acronym / sponsor ID
- PADELTO / 21849
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227,613 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- External supplier: HEVA
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 1 Apr 2021 (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 a study to learn more about French patients who have peripheral artery disease (PAD) and who have had a revascularization procedure. With this procedure, doctors use surgery or a thin tube (called a catheter) to open a narrow or blocked blood vessel in the lower limbs.
In a previous Bayer trial called VOYAGER PAD, researchers studied Xarelto in participants with PAD who had recently had a revascularization procedure in their lower leg. The researchers studied how well Xarelto worked and how safe it was in these participants.
Based on the results of the VOYAGER PAD trial, the researchers in this study want to learn the number of patients with PAD who had a revascularization procedure in France from January 1st, 2016 to December 31st, 2019. This can help the researchers learn more about the target population (a specific group of people) who could potentially receive treatment with Xarelto.
Xarelto is available for doctors in France to prescribe to patients who have the following conditions:
- to reduce the risk of another heart attack or of dying from a disease related to the heart or the blood vessels in adults with acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) who have had an increase in certain cardiac blood tests
- to reduce the risk of getting blot clots (atherothrombotic events) in adults at a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms
- to prevent blood clots in the veins after a hip or knee replacement operation in adults
- to prevent blood clots in brain (stroke) and other blood vessels in the body in adults who have a form of irregular heart rhythm called non-valvular atrial fibrillation
- to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of the legs and/or lungs in adults
- to treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs in full-term newborn babies, infants and toddlers, children and adolescents below 18 years following an initial treatment of at least 5 days with injectable medicines used to treat blood clots
All the patients in this study will have PAD in their lower leg. They will all have had a revascularization procedure during a hospital stay in France between January 1st, 2016 and December 31st, 2019. The researchers will collect the patients' health data from the French National Health Insurance (NHI) hospital discharge database (PMSI). The researchers will look at the health data from all patients with PAD who had a revascularization procedure and also patients who could have joined the VOYAGER PAD trial. This group will not include any patients who have health conditions other than PAD.
The researchers will review each patient's medical records until December 31st, 2019 or earlier if the patient has died. The researchers will also look at any previous medical records from the date of each patient's revascularization procedure back to January 1st, 2014. The researchers will use these medical records to look for any health conditions other than PAD that the patients may have had before their revascularization procedure after January 1st 2016.
The main question the researchers want to answer in this study is: how many patients with PAD had a revascularization procedure between January 1st, 2016 and December 31st, 2019?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| French PAD revascularized population | – | Procedure: Lower limb revascularizationPatients with lower-extremity peripheral artery disease (PAD) who have undergone lower limb revascularization (PAD revascularized population) in France from 2016 to 2019. |
| French VOYAGER PAD-like population | – | Procedure: Lower limb revascularizationVOYAGER PAD-like patients in France from 2016 to 2019. This population will be constituted to fit the VOYAGER PAD clinical trial population. It will be created using the VOYAGER PAD exclusion criteria and resembles a subgroup of the PAD revascularized population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- PAD revascularized population; Patients with lower-extremity PAD having undergone a lower limb revascularization during a hospital stay in France occurring between January 1, 2016 and ending by December 31, 2019 will be included into the study at the time of a lower limb revascularization hospital stay. VOYAGER PAD-like population: This population will be constituted to fit the VOYAGER PAD clinical trial population. It will be created using the VOYAGER PAD exclusion criteria.
Key inclusion criteria (3 listed)
- Patients with hospital stays identified through ICD-10 and surgical procedure (CCAM) codes:
- Patient with a lower-extremity PAD.
- Patient with a lower limb revascularization procedure.
Key exclusion criteria (15 listed)
- None
- Patients presenting the following medical history at index date will be excluded from the VOYAGER PAD-like population.:
- Prior revascularization within 10 days of the qualifying lower limb revascularization
- ALI within 2 weeks prior to the qualifying lower limb revascularization
- Patients with major tissue loss (defined as significant ulceration/gangrene proximal to the metatarsal heads, i.e. heel or midfoot)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower limb revascularizationFrench population of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization. | Procedure or surgery | French PAD revascularized population |
| Lower limb revascularizationFrench population of patients matching the VOYAGER PAD exclusion criteria resembling a subgroup of the PAD revascularized population. | Procedure or surgery | French VOYAGER PAD-like population |
Primary outcome
Number of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization
Time frame: 3 years
Retrospective data analysis carried out on the French National Health Insurance's (NHI) hospital discharge database (PMSI) on PAD revascularized population in France from 2016 to 2019.
5 secondary outcomes
Number of patients with lower-extremity peripheral artery disease matching the VOYAGER PAD inclusion and exclusion criteria
Time frame: 3 years
Characteristics of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization
Time frame: 3 years
Characteristics of patients with lower-extremity peripheral artery disease matching the VOYAGER PAD inclusion and exclusion criteria
Time frame: 3 years
Risk of major thrombotic vascular events in patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization
Time frame: 2 years
Risk of major thrombotic vascular events in patients matching the VOYAGER PAD inclusion and exclusion criteria
Time frame: 2 years
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 25 Apr 2022.
- 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.clinicalstudydatarequest.com 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 Study sponsors 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 Artery Disease, run by Bayer at 1 site in France.
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 15 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 25 Apr 2022. 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 France. 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?
Number of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization (time frame: 3 years). 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 25 Apr 2022.