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临床试验/NCT06047002
NCT06047002招募中不适用

Panther (Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease)

University of Leicester1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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