Clinical trial NCT06047002: Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Official title: Panther (Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: 18 months
Secondary outcomes:
measure: To examine whether resistance to antiplatelet therapy is associated with major adverse cardiac or limb events during the follow up interval of one year
timeFrame: 18 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester
Study officials:
affiliation: University of Leicester
name: Sarah Jane Messeder, MBChB
role: PRINCIPAL_INVESTIGATOR
References: