Peripheral Arterial DiseaseNCT06047002
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Peripheral arterial disease (PAD) is a condition where the blood vessels in the legs get blocked. It affects one out of every five adults over the age of 65. As it is the main cause of amputations, the NHS performs over 20,000 operations every year to prevent them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2022to 31 Dec 2024
- 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 population of interest is patients presenting electively or as an emergency with: * Disabling intermittent claudication (Rutherford stage III) * Ischaemic rest pain (Rutherford Stage IV) * Minor tissue loss due to peripheral arterial disease (Rutherford Stage V) * Ulceration or gangrene due to peripheral arterial disease (Rutherford Stage VI). Patients presenting with diabetic foot infection or diabetic foot sepsis will not be considered for
Who may be able to join
- Patients over the age of 18 years.
- Patients with severely symptomatic aorto-iliac and infra-inguinal peripheral arterial disease.
- Patients with the ability to provide written informed consent.
- Patients on antiplatelet therapy
Who cannot join
- Patients under the age of 18 years.
- Patients unable or unwilling to provide written informed consent.
- Patients with acute limb ischaemia of the lower limb.
- Patients with aneurysmal disease of the arteries of the lower limb.
- Patients with severe diabetic foot sepsis.
- Patients with a known history of clotting disorders
- Patients with inherited bleeding disorders
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Leicester
Leicester, LE3 9QP
Matt Bown, Professor, 0044 (0)116 2502381, mjb42@le.ac.uk
Sarah Jane Messeder, MBChB, 0044 (0)116 2502381, sjm104@le.ac.uk
About this study
Official title: Panther (Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease)
Peripheral arterial disease (PAD) is a condition where the blood vessels in the legs get blocked. It affects one out of every five adults over the age of 65. As it is the main cause of amputations, the NHS performs over 20,000 operations every year to prevent them. People with PAD benefit from tablets to thin their blood as this improves outcomes after surgery and prevents heart attacks and strokes. The main tablets for this purpose are aspirin and clopidogrel. These work in most people, but up to a third of patients do not get any benefit from them, as their bodies cannot process them. We call this resistance to therapy (RT).Because blood thinning is particularly important after operations people with RT may be at higher risk of their operation failing leading to amputation and/or problems such as heart attacks and strokes. Testing for RT has not traditionally been performed because it requires complex laboratory procedures. Recent development in technology now means that bedside tests are available for RT. We will use a simple beside test for RT in patients with severe PAD. We will use this test to see how many of these patients have RT and whether this affects their risk of complications after an operation. If we find that RT does affect outcomes for patients with PAD, the information obtained will be used to plan future research to determine if changing blood thinning therapy in people with CR improves their outcomes after surgery.
Read the detailed description
Patients with peripheral arterial disease, a condition whereby arteries in the legs become narrow or blocked, are not only at a higher risk of limb loss but also of suffering heart attacks and strokes. To manage this risk and to ensure surgery for the blocked arteries is successful, they are prescribed tablets to make their blood less sticky, called antiplatelet agents. Aspirin and clopidogrel are the two tablets most commonly prescribed for this purpose.
In some patients, these two tablets are not effective as expected, because of interactions with other medications they are on or because their bodies cannot process them. This is known as resistance to antiplatelet therapy.
The main aim of this study is to establish how common resistance to aspirin and clopidogrel is in patients with peripheral arterial disease.
- Conditions
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the feasibility of using the VerifyNow PRU and Aspirin assays to obtain estimates of the prevalence of resistance to antiplatelet therapy (aspirin & clopidogrel) in patients with symptomatic peripheral arterial disease.
Prevalence of resistance to aspirin and clopidogrel will be calculated as:
Prevalence = (Number of patients resistant/Total study population) * 100
Total estimated sample size of 150 participants.
The VerifyNow PRU Test (CPT85576) is reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor.
<180 PRU - suggests P2Y12 inhibitor effect 180-376 PRU - suggests lack of P2Y12 inhibitor effect.
The VerifyNow Aspirin (CPT 85576) test is reported as Aspirin Reaction Units (ARU). ARU measures the extent of platelet aggregation in the presence of Arachidonic acid.
</= 549 ARU - Evidence of platelet dysfunction due to aspirin > 550 ARU - No evidence of aspirin-induced platelet dysfunction.
Measured: 18 months
Secondary outcomes (1)
To examine whether resistance to antiplatelet therapy is associated with major adverse cardiac or limb events during the follow up interval of one year
Risk ratio = Cumulative incidence of major adverse cardiac/limb events in the Resistant Groups/Cumulative Incidence of Major events in the non-Resistant group
Major adverse cardiac events = myocardial infarction, stroke, cardiovascular death Major adverse limb events = major amputation, acute limb ischaemia, re-operation
Events will be assessed through interrogation of electronic medical records and phone calls with participants at both 6 months and one year follow up.
Total estimated sample size of 150 participants.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start29 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Jane Messeder, MBChB, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047002
- Sponsor's protocol ID
- 0829
- Status last verified
- Aug 2023
- First submitted
- 6 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panther (Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease)
- ClinicalTrials.gov ID
- NCT06047002
- Acronym / sponsor ID
- 0829
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
Peripheral arterial disease (PAD) is a condition where the blood vessels in the legs get blocked. It affects one out of every five adults over the age of 65. As it is the main cause of amputations, the NHS performs over 20,000 operations every year to prevent them. People with PAD benefit from tablets to thin their blood as this improves outcomes after surgery and prevents heart attacks and strokes. The main tablets for this purpose are aspirin and clopidogrel. These work in most people, but up to a third of patients do not get any benefit from them, as their bodies cannot process them. We call this resistance to therapy (RT).Because blood thinning is particularly important after operations people with RT may be at higher risk of their operation failing leading to amputation and/or problems such as heart attacks and strokes. Testing for RT has not traditionally been performed because it requires complex laboratory procedures. Recent development in technology now means that bedside tests are available for RT. We will use a simple beside test for RT in patients with severe PAD. We will use this test to see how many of these patients have RT and whether this affects their risk of complications after an operation. If we find that RT does affect outcomes for patients with PAD, the information obtained will be used to plan future research to determine if changing blood thinning therapy in people with CR improves their outcomes after surgery.
Detailed description
Patients with peripheral arterial disease, a condition whereby arteries in the legs become narrow or blocked, are not only at a higher risk of limb loss but also of suffering heart attacks and strokes. To manage this risk and to ensure surgery for the blocked arteries is successful, they are prescribed tablets to make their blood less sticky, called antiplatelet agents. Aspirin and clopidogrel are the two tablets most commonly prescribed for this purpose.
In some patients, these two tablets are not effective as expected, because of interactions with other medications they are on or because their bodies cannot process them. This is known as resistance to antiplatelet therapy.
The main aim of this study is to establish how common resistance to aspirin and clopidogrel is in patients with peripheral arterial disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of interest is patients presenting electively or as an emergency with: * Disabling intermittent claudication (Rutherford stage III) * Ischaemic rest pain (Rutherford Stage IV) * Minor tissue loss due to peripheral arterial disease (Rutherford Stage V) * Ulceration or gangrene due to peripheral arterial disease (Rutherford Stage VI). Patients presenting with diabetic foot infection or diabetic foot sepsis will not be considered for
Key inclusion criteria (4 listed)
- Patients over the age of 18 years.
- Patients with severely symptomatic aorto-iliac and infra-inguinal peripheral arterial disease.
- Patients with the ability to provide written informed consent.
- Patients on antiplatelet therapy
Key exclusion criteria (7 listed)
- Patients under the age of 18 years.
- Patients unable or unwilling to provide written informed consent.
- Patients with acute limb ischaemia of the lower limb.
- Patients with aneurysmal disease of the arteries of the lower limb.
- Patients with severe diabetic foot sepsis.
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
To examine the feasibility of using the VerifyNow PRU and Aspirin assays to obtain estimates of the prevalence of resistance to antiplatelet therapy (aspirin & clopidogrel) in patients with symptomatic peripheral arterial disease.
Time frame: 18 months
Prevalence of resistance to aspirin and clopidogrel will be calculated as: Prevalence = (Number of patients resistant/Total study population) * 100 Total estimated sample size of 150 participants. The VerifyNow PRU Test (CPT85576) is reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor. <180 PRU - suggests P2Y12 inhibitor effect 180-376 PRU - suggests lack of P2Y12 inhibitor effect. The VerifyNow Aspirin (CPT 85576) test is reported as Aspirin Reaction Units (ARU). ARU measures the extent of platelet aggregation in the presence of Arachidonic acid. </= 549 ARU - Evidence of platelet dysfunction due to aspirin > 550 ARU - No evidence of aspirin-induced platelet dysfunction.
1 secondary outcome
To examine whether resistance to antiplatelet therapy is associated with major adverse cardiac or limb events during the follow up interval of one year
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Sarah Jane Messeder, MBChB principal investigator
University of Leicester
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, run by University of Leicester at 1 site in United Kingdom.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matt Bown, Professor (0044 (0)116 2502381, mjb42@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the feasibility of using the VerifyNow PRU and Aspirin assays to obtain estimates of the prevalence of resistance to antiplatelet therapy (aspirin & clopidogrel) in patients with symptomatic peripheral arterial disease. (time frame: 18 months). 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 21 Sep 2023.