BACKGROUND

Chronic Limb Threatening Ischaemia (CLTI) is the most severe form of peripheral arterial disease (PAD). If left untreated, it can lead to leg amputation or even death. Improving treatment outcomes for peopl with CLTI is a crucial clinical and research priority for both clinicians and patients.
​CLTI is treated both medically and surgically. Surgical treatment may be a minimally-invasive procedure known as endovascular intervention, open surgery such as bypass or a combination of both. The choice depends on the types of blockage and medical fitness of an individual patient. 
​After undergoing an endovascular intervention, patients receive antithrombotic (blood thinning) medications. These include antiplatelet and/or anticoagulant drugs, which help prevent blood clots and improve overall results by reducing the risk of ischaemic and cardiovascular events.
Despite every patient receiving blood thinning medication, there is limited evidence from randomised controlled trials (RCTs) on the best antithrombotic treatments for CLTI in the UK. 

Trial Design

The CLARITY trial is a randomised trial that will compare three commonly used treatment regimens in the NHS after angioplasty.

Participants will be randomly chosen to have one of the following treatments for up to 36 months:
1)           Clopidogrel
2)           Aspirin and Clopidogrel
3)           Aspirin and Rivaroxaban
​
The trial is designed with a 9-month internal pilot and an adaptive interim futility analysis. 

Aim of Research

The CLARITY trial aims to evaluate the clinical and cost-effectiveness of three antithrombotic regimens following endovascular lower limb revascularisation.  
​PRIMARY OUTCOMES
Composite event-free survival time of:
  • Acute limb ischaemia
  • Major lower limb amputation
  • Myocardial infarction
  • Ischaemic stroke and
  • All-cause mortality 
CLARITY is a pragmatic trial, which will follow real-world, routine clinical practice. Participants will therefore not need to attend any additional in-person monitoring sessions or appointments as part of the trial, and will only need to attend routine follow-up appointments with their medical team. 

CLARITY SUMMARY

  • Sample size: 1,239
  • Roughly 20 participating NHS Hospital Sites
  • Randomisation will be 1:1:1 (to Clopidogrel or Aspirin and Clopidogrel, or Aspirin and Rivaroxaban).
  • ​Treatment duration: 12-36 months.
  • Follow-up: 2 and 6 month and annually for up to 3 years via phone, online or post.
  • Participant follow-up will include questionnaires on wellbeing and daily activities, healthcare and resource use.
  • Outcomes also recorded through medical records.
  • Optional qualitative interview with a subset of participants and healthcare professionals to evaluate the delivery of the CLARITY trial and trial interventions.
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