Peripheral Arterial DiseaseMPANCT07169513
Mechanistic Study of Anti-Platelet Therapy in Atherosclerosis
A study testing Aspirin 75 mg daily, Clopidogrel 75 mg daily and Clopidgrel 75 mg daily in people with Peripheral Arterial Disease and Silent Atherosclerosis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Many people have a higher chance of getting heart problems. These individuals include people who are very overweight (obesity), have high blood pressure (hypertension), diabetes, or other health concerns. Heart problems often happen because of a condition called atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Silent Atherosclerosis
- What is being tested?
- Aspirin 75 mg daily, Clopidogrel 75 mg daily and Clopidgrel 75 mg daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Group 1:
- Male or female age 18 years or older
- Willing to participate in the study, and able to give informed consent
- Negative pregnancy test for a childbearing age woman
- Receiving standard of care
- Confirmed atherosclerotic cardiovascular risk based on clinical assessment
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- Group 2:
- Male or female age 18 years or older
- Willing to participate in the study, and able to give informed consent
- Receiving standard of care
- Negative pregnancy test for a childbearing age woman
- Confirmed diagnosis of peripheral arterial disease (ankle-brachial index below 0.9) with Rutherford grade 1-3.
Who cannot join
- Group 1:
- Diabetes
- Receiving any anti-platelet medications within the last two weeks
- Receiving any anticoagulant medications within the last two weeks
- Receiving statin medications within the last two weeks
- Known major organ dysfunction
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- Significant co-morbidities
- Pregnancy or lactating woman
- Unwilling, or unable to give informed consent
- Presence of co-existing autoimmune disease
- Hypersensitivity to aspirin or clopidogrel
- Severe hepatic impairment (Child-Pugh grade C)
- Active peptic ulcer
- Presence of co-existing inflammatory or autoimmune diseases
- Frequent use of medications known to affect platelet function five days before baseline phlebotomy and during the study
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Antihistamines
- Selective serotonin reuptake inhibitors
- Platelet count < 100 × 109 /L or > 450 × 109 /L
- Anaemia
- Any known bleeding diathesis
- Currently involved in other clinical research studies
- Group 2:
- Diabetes
- Patients with PAD Rutherford category of more than 3
- Receiving any anticoagulant medications within the last two weeks
- Known major organ dysfunction
- Pregnancy or lactating woman
- Unwilling, or unable, to give informed consent
- Hypersensitivity to aspirin or clopidogrel
- Severe hepatic impairment (Child-Pugh grade C)
- Active peptic ulcer
- Presence of co-existing autoimmune disease
- Frequent use of medications known to affect platelet function five days before baseline phlebotomy and during the study
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Antihistamines
- Selective serotonin reuptake inhibitors
- Platelet count < 100 × 109 /L or > 450 × 109 /L
- Anaemia
- Any known bleeding diathesis
- Currently involved in other clinical research studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eman Al Musalami contact
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Ashish Patel, 0442071880216, ashish.patel@kcl.ac.uk
Eman Al Musalami, eman.1.al_musalami@kcl.ac.uk
About this study
Official title: Targeting the Inflammasome With Anti-platelet Therapy: A Mechanistic Study
Many people have a higher chance of getting heart problems. These individuals include people who are very overweight (obesity), have high blood pressure (hypertension), diabetes, or other health concerns. Heart problems often happen because of a condition called atherosclerosis. This condition is when the arteries, which are the blood vessels carrying blood from the heart, become hard and inflamed (swollen and irritated) at the same time. Atherosclerosis causes arteries narrowing, making it harder for blood to flow through. The signs of atherosclerosis can be mild, like feeling chest pain (called angina) because the heart isn't getting enough blood. In more serious cases, it can lead to a heart attack.
Think of inflammation as the body's natural alarm system. When a person gets hurt or sick, the body releases special chemicals. These chemicals tell the immune system (the body's defence team) to come and help. Their job is to heal the injury or fight off the infection.
Read more
While inflammation is usually good, sometimes it can go wrong. Atherosclerosis is one of these conditions where the inflammation in the blood vessels becomes abnormal. This ongoing inflammation can harm the body and lead to various heart problems and other health issues not directly related to the heart.
In atherosclerosis, platelets (cell fragments in our blood that form clots and stop or prevent bleeding) bind to monocytes (a type of white blood cell and a type of phagocyte - part of the immune system) to form clusters called monocyte platelet aggregate (MPA). Studies have shown that people with atherosclerosis have higher levels of the monocytes clustering with the platelets. This aggregate contributes to the worsening of atherosclerosis. Additionally, this aggregate can predict the risk of developing various cardiac diseases.
Anti-platelet (anti-clotting) medications work by stopping platelet function. In this study, investigators are giving participants two different anti-platelet medications to study the effect of these medications on the level of MPA. The target people of our study are the people with silent atherosclerosis (there is an accumulation of lipids in the blood vessels but no signs or symptoms). No existing research demonstrates whether the two most commonly prescribed anti-platelets (aspirin and clopidogrel) can help reduce MPA levels. This study aims to show the effect of anti-platelet medications on the level of MPA and other inflammatory indicators. The two medications are aspirin and clopidogrel. These two drugs are already available in the market and widely used by different patients for different reasons. Aspirin and clopidogrel have different modes of action to stop platelet function.
- Being tested
- Aspirin 75 mg daily, Clopidogrel 75 mg daily, Clopidgrel 75 mg daily, Aspirin 75 mg daily + Clopidgrel 75 mg daily
- 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.
Aspirin 75 mg dailyDrug
For group 1 patients
Clopidogrel 75 mg dailyDrug
For group 2 patients
Clopidgrel 75 mg dailyDrug
For group 1 patients
Aspirin 75 mg daily + Clopidgrel 75 mg dailyDrug
For group 2 patients
| Study group | Role | What they receive |
|---|---|---|
| Aspirin/Clopidogrel | Active comparator | Not described Receives: Drug: Aspirin 75 mg daily; Drug: Clopidogrel 75 mg daily |
| Clopidogrel/DAPT | Active comparator | Not described Receives: Drug: Clopidgrel 75 mg daily; Drug: Aspirin 75 mg daily + Clopidgrel 75 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte-platelet aggregates (MPAs)
Changes in the percentages of monocyte-platelet aggregates (MPAs) in two groups of patients following treatment with aspirin and clopidogrel using flow cytometry
Measured: Maximum 14 weeks
Secondary outcomes (3)
Monocyte and platelet activation/phenotype
Measure the effect of aspirin, clopidogrel, and their combination on monocyte and platelet activation/phenotype using flow cytometry
Measured: Maximum 14 weeks
Circulating mediators of inflammation
Measure the influence of aspirin, clopidogrel, and their combination on the level of circulating mediators of inflammation using multiplex Luminex assay
Measured: Maximum 14 weeks
Gene expression
Determine how aspirin, clopidogrel, and their combination modulate gene expression using single-cell RNA sequencing
Measured: Maximum 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (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.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a randomised, single-blind, controlled crossover trial in two groups of patients following treatment with aspirin and clopidogrel; (1) patients with abnormally high carotid intima-media thickness (cIMT) - defined by an intima-media thickness (IMT) above the 75th centile for age and sex; and (2) patients with a confirmed diagnosis of PAD (ankle-brachial index below 0.9) with Rutherford classification grade of 1-3.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169513
- Sponsor's protocol ID
- 174661
- Acronym
- MPA
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Inflammasome With Anti-platelet Therapy: A Mechanistic Study
- ClinicalTrials.gov ID
- NCT07169513
- Acronym / sponsor ID
- MPA / 174661
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 Sep 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.
Many people have a higher chance of getting heart problems. These individuals include people who are very overweight (obesity), have high blood pressure (hypertension), diabetes, or other health concerns. Heart problems often happen because of a condition called atherosclerosis. This condition is when the arteries, which are the blood vessels carrying blood from the heart, become hard and inflamed (swollen and irritated) at the same time. Atherosclerosis causes arteries narrowing, making it harder for blood to flow through. The signs of atherosclerosis can be mild, like feeling chest pain (called angina) because the heart isn't getting enough blood. In more serious cases, it can lead to a heart attack.
Think of inflammation as the body's natural alarm system. When a person gets hurt or sick, the body releases special chemicals. These chemicals tell the immune system (the body's defence team) to come and help. Their job is to heal the injury or fight off the infection.
While inflammation is usually good, sometimes it can go wrong. Atherosclerosis is one of these conditions where the inflammation in the blood vessels becomes abnormal. This ongoing inflammation can harm the body and lead to various heart problems and other health issues not directly related to the heart.
In atherosclerosis, platelets (cell fragments in our blood that form clots and stop or prevent bleeding) bind to monocytes (a type of white blood cell and a type of phagocyte - part of the immune system) to form clusters called monocyte platelet aggregate (MPA). Studies have shown that people with atherosclerosis have higher levels of the monocytes clustering with the platelets. This aggregate contributes to the worsening of atherosclerosis. Additionally, this aggregate can predict the risk of developing various cardiac diseases.
Anti-platelet (anti-clotting) medications work by stopping platelet function. In this study, investigators are giving participants two different anti-platelet medications to study the effect of these medications on the level of MPA. The target people of our study are the people with silent atherosclerosis (there is an accumulation of lipids in the blood vessels but no signs or symptoms). No existing research demonstrates whether the two most commonly prescribed anti-platelets (aspirin and clopidogrel) can help reduce MPA levels. This study aims to show the effect of anti-platelet medications on the level of MPA and other inflammatory indicators. The two medications are aspirin and clopidogrel. These two drugs are already available in the market and widely used by different patients for different reasons. Aspirin and clopidogrel have different modes of action to stop platelet function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study is a randomised, single-blind, controlled crossover trial in two groups of patients following treatment with aspirin and clopidogrel; (1) patients with abnormally high carotid intima-media thickness (cIMT) - defined by an intima-media thickness (IMT) above the 75th centile for age and sex; and (2) patients with a confirmed diagnosis of PAD (ankle-brachial index below 0.9) with Rutherford classification grade of 1-3.
| Arm | Type | Receives |
|---|---|---|
| Aspirin/Clopidogrel | Active comparator | Drug: Aspirin 75 mg daily, Drug: Clopidogrel 75 mg daily |
| Clopidogrel/DAPT | Active comparator | Drug: Clopidgrel 75 mg daily, Drug: Aspirin 75 mg daily + Clopidgrel 75 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female age 18 years or older
- Willing to participate in the study, and able to give informed consent
- Negative pregnancy test for a childbearing age woman
- Receiving standard of care
- Confirmed atherosclerotic cardiovascular risk based on clinical assessment
Key exclusion criteria (41 listed)
- Diabetes
- Receiving any anti-platelet medications within the last two weeks
- Receiving any anticoagulant medications within the last two weeks
- Receiving statin medications within the last two weeks
- Known major organ dysfunction
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 |
|---|---|---|
| Aspirin 75 mg dailyFor group 1 patients | Drug | Aspirin/Clopidogrel |
| Clopidogrel 75 mg dailyFor group 2 patients | Drug | Aspirin/Clopidogrel |
| Clopidgrel 75 mg dailyFor group 1 patients | Drug | Clopidogrel/DAPT |
| Aspirin 75 mg daily + Clopidgrel 75 mg dailyFor group 2 patients | Drug | Clopidogrel/DAPT |
Primary outcome
Monocyte-platelet aggregates (MPAs)
Time frame: Maximum 14 weeks
Changes in the percentages of monocyte-platelet aggregates (MPAs) in two groups of patients following treatment with aspirin and clopidogrel using flow cytometry
3 secondary outcomes
Monocyte and platelet activation/phenotype
Time frame: Maximum 14 weeks
Circulating mediators of inflammation
Time frame: Maximum 14 weeks
Gene expression
Time frame: Maximum 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- 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.
Eman Al Musalami contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin 75 mg daily, Clopidogrel 75 mg daily and Clopidgrel 75 mg daily in people with Peripheral Arterial Disease and Silent Atherosclerosis, run by Guy's and St Thomas' NHS Foundation Trust 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 12 inclusion and 41 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: opening soon, as of the sponsor's last update on 11 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashish Patel (0442071880216, ashish.patel@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte-platelet aggregates (MPAs) (time frame: Maximum 14 weeks). 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 11 Sep 2025.