Status:
NOT_YET_RECRUITING
Mechanistic Study of Anti-Platelet Therapy in Atherosclerosis
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Peripheral Arterial Disease
Silent Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 conce...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07169513
Start Date
October 1 2025
End Date
July 1 2026
Last Update
September 11 2025
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH