Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease

NCT06047002 | Unknown

• 1 other identifier: 0829
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University Hospitals Leicester

Leicester, LE3 9QP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples are being stored for future research.

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Sarah Jane Messeder, MBChB

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Bown, Professor

CONTACT

0044 (0)116 2502381; mjb42@le.ac.uk

Sarah Jane Messeder, MBChB

CONTACT

0044 (0)116 2502381; sjm104@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start: September 29, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)