EUCLID – Examining use of ticagrelor in PAD patients

• Research type

  Research Study

• Full title

  A randomised, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischaemic stroke in patients with established Peripheral Artery Disease (EUCLID – Examining Use of tiCagreLor In paD)

• IRAS ID

  112578

• Contact name

  Andrew Bradbury

• Eudract number

  2011-004616-36

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a randomised, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischaemic stroke in patients with established Peripheral Artery Disease (PAD). The aim of the study is to see if a drug called ticagrelor, which is approved for another use in the UK, can prevent a heart attack, stroke or death due to heart problems in patients who have PAD, compared with clopidogrel. Narrowing of the arteries of the body, called atherosclerosis, is a disease that can affect the heart, the brain and other parts of the body. Significant atherosclerosis of the arteries supplying the limbs, upper extremity, kidneys, and gastrointestinal tract is referred to as PAD. Consequences of lower extremity PAD include leg pain when walking or even at rest, leg ulcers, or if very severe, loss of limb. Patients with PAD have an increased risk of heart attack, stroke, and cardiovascular death. Patients will be randomised to receive either active ticagrelor or active clopidogrel. Matching placebos will be used to maintain blinding. In this study, patients will visit the study centre approximately 8 to 11 times over a minimum period of approximately 18 months up to approximately 36 months, and have a phone call in between some of the study visits. A series of clinical assessments will be performed throughout the study including, but not exclusive to ankle brachial index (ABI), toe brachial index (TBI), electrocardiogram (ECG), vital signs, physical examinations, laboratory tests and questionnaires. An estimated 11,500 patients will take part in approximately 25 countries, with about 200 patients from the UK.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0395

• Date of REC Opinion

  3 Dec 2012

• REC opinion

  Further Information Favourable Opinion