EUCLID - A Randomized, Double-Blind, Parallel Group, Multicenter 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 Arte

Confidential Human Clinical Trial PHASE 3 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) Objectives Primary objective The primary objective of the study is to compare the effect oflong-term treatment with ticagrelor vs. clopidogrel on the event rate ofthe composite of cardiovascular (CV) death, myocardial infarction (MI), and ischaemic stroke (defined as any stroke not demonstrated to be primarily haemorrhagic) in patients with established PAD (see definition Section 4.1). The primary efficacy variable is time from randomisation to first occurrence of any event in the composite ofCV death, MI, and ischaemic stroke. Secondary objectives The secondary objectives (presented in hierarchical order - see Section 2.2 for details) ofthe study are to compare the effect oflong-tenn treatment with ticagrelor vs. c1opidogrel, in patients with established PAD (see definition Section 4.1): 1. Composite ofCV death and MI 2. CV death 3. MI 4. All-cause mortality 5. Composite ofCV death, MI, and all-cause stroke (ischaemic or haemolThagic) 6. All revascularisation (coronary and peripheral [limb, mesenteric, renal, carotid and other]) Other objectives Other objectives (see detail in Section 2.2.1) are exploratory with the purpose of comparing other possible 10ng-telTU treatment effects ofticagrelor vs. clopidogrel, in patients with established PAD on: Net clinical benefit composed of primary outcome events and major bleeding Non-CV death Lower extremity revascularisation Progression of the clinical/symptomatic status of the limb Progression of the haemodynamic status of the limb Major amputation due to PAD Quality of life/functional status Primary efficacy and primary safety variable subgroup analysis (eg, clinical stage, prior MI, diabetes, hyperlipidemia, tobacco use, etc) CV-related hospitalisation Long term cost-effectiveness