CLARITY PAD

• Research type

  Research Study

• Full title

  CLopidogrel, Aspirin and RIvaroxaban after revascularisation with angioplasTY for limb-threatening Peripheral Arterial Disease (CLARITY PAD)

• IRAS ID

  1007268

• Contact name

  Christopher Twine

• Contact email

  christopher.twine@bristol.ac.uk

• Sponsor organisation

  North Bristol NHS Trust

• ISRCTN Number

  ISRCTN30648419

• Research summary

  Blocked leg arteries, often caused by diabetes or smoking, are increasingly common and can result in potentially severe consequences like amputation or even death if left untreated. In the UK, between 16,500 and 30,000 people die and 3,500 face amputations due to heavily blocked leg arteries annually. Each year, over 4,000 angioplasty medical procedures are conducted in the UK to widen narrowed or blocked arteries using a balloon or stent. After an angioplasty, patients typically receive medications known as “blood thinners” to prevent blood clots and lower the chance of needing an amputation. Despite the widespread use of various tablet combinations by vascular surgeons in the UK, the optimal blood thinners for effectiveness and safety remain unknown.
  This research will compare three commonly used blood thinners after angioplasty: Clopidogrel alone, Aspirin and Clopidogrel, and Aspirin and Rivaroxaban. The research will be ‘randomised’, meaning that patients will be randomly chosen by a computer to receive one of the three treatments, ensuring equal chances for each. Everything else will be the same.
  This research will involve roughly 20 vascular units in the UK, with 1,239 participants undergoing angioplasty in the lower leg due to blocked arteries. Within 10 days of angioplasty, participants will start taking the assigned blood thinners for up to three years. We will ask participants about their quality of life and will be monitored for health problems such as further blockages, amputations, heart attacks, strokes and serious bleeding. The research aims to determine the optimal blood thinners for preventing complications of blocked arteries after angioplasty without causing too much bleeding. The research will also assess how much value these treatments provide in terms of their cost for the National Health Service (NHS). The results are expected to help improve the care of many patients needing angioplasty in the future.

• REC name

  Wales REC 5

• REC reference

  24/WA/0211

• Date of REC Opinion

  21 Aug 2024

• REC opinion

  Further Information Favourable Opinion