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A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic 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 of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the 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 of CV death, MI, and ischaemic stroke. Secondary objectives- The secondary objectives (presented in hierarchical order see Section 2.2 for details) of the study are to compare the effect of long-term treatment with ticagrelor vs. clopidogrel, in patients with established PAD (see definition Section 4.1): 1. Composite of CV death, MI, Ischemic Stroke and Acute Limb Ischemia (ALI) requiring hospitalization 2. CV death 3. MI 4. All-cause mortality 5. Composite of CV death, MI, and all-cause stroke (ischaemic or haemorrhagic) 6. Acute Limb Ischemia (ALI) requiring hospitalization 7. All Lower Extremity Revascularization 8. All revascularization procedures Other objectives - Other objectives (see detail in Section 2.2.1) are exploratory with the purpose of comparing other possible long-term treatment effects of ticagrelor vs. clopidogrel, in patients with established PAD on:  Net clinical benefit composed of primary outcome events and fatal or intracranial bleeding  Net clinical benefit composed of primary outcome events and major bleeding  Non-CV death  Progression of the clinical/symptomatic status of the limb  Progression of the haemodynamic status of the limb  All amputations due to PAD  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 Safety objectives Non-serious adverse events (AEs) of interest (i.e., bleeding events, dyspnoea, renal impairment/increased creatinine, bradyarrhythmia, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers), adverse events that are ongoing at the time of permanent discontinuation of study medication due to an adverse event (DAEs) and all serious adverse events (SAEs) will be reviewed within the context of the earlier safety experience with the drug. The overall safety objective of this study is to assess the safety and tolerability of long-term therapy with ticagrelor compared with clopidogrel in patients with established PAD after first dose of study medication. Bleeding events will be analyzed using the Thrombolysis in Myocardial Infarction Study Group (TIMI), Bleeding Academic Research Consortium (BARC) and International Society on Thrombosis and Haemostasis (ISTH) definitions, and those used in the PLATO (PLATelet inhibition and patient Outcomes) study. Specific focus will be on:  Time to first TIMI major bleeding event (primary safety objective)  Time to first TIMI major or minor bleeding event  Time to first PLATO major bleeding event  Time to discontinuation of study medication due to any major bleeding event  Evaluation of non-serious AEs of interest, DAEs and SAEs

Objectives: Primary objective- The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the 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 of CV death, MI, and ischaemic stroke. Secondary objectives- The secondary objectives (presented in hierarchical order see Section 2.2 for details) of the study are to compare the effect of long-term treatment with ticagrelor vs. clopidogrel, in patients with established PAD (see definition Section 4.1): 1. Composite of CV death, MI, Ischemic Stroke and Acute Limb Ischemia (ALI) requiring hospitalization 2. CV death 3. MI 4. All-cause mortality 5. Composite of CV death, MI, and all-cause stroke (ischaemic or haemorrhagic) 6. Acute Limb Ischemia (ALI) requiring hospitalization 7. All Lower Extremity Revascularization 8. All revascularization procedures Other objectives - Other objectives (see detail in Section 2.2.1) are exploratory with the purpose of comparing other possible long-term treatment effects of ticagrelor vs. clopidogrel, in patients with established PAD on:  Net clinical benefit composed of primary outcome events and fatal or intracranial bleeding  Net clinical benefit composed of primary outcome events and major bleeding  Non-CV death  Progression of the clinical/symptomatic status of the limb  Progression of the haemodynamic status of the limb  All amputations due to PAD  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 Safety objectives Non-serious adverse events (AEs) of interest (i.e., bleeding events, dyspnoea, renal impairment/increased creatinine, bradyarrhythmia, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers), adverse events that are ongoing at the time of permanent discontinuation of study medication due to an adverse event (DAEs) and all serious adverse events (SAEs) will be reviewed within the context of the earlier safety experience with the drug. The overall safety objective of this study is to assess the safety and tolerability of long-term therapy with ticagrelor compared with clopidogrel in patients with established PAD after first dose of study medication. Bleeding events will be analyzed using the Thrombolysis in Myocardial Infarction Study Group (TIMI), Bleeding Academic Research Consortium (BARC) and International Society on Thrombosis and Haemostasis (ISTH) definitions, and those used in the PLATO (PLATelet inhibition and patient Outcomes) study. Specific focus will be on:  Time to first TIMI major bleeding event (primary safety objective)  Time to first TIMI major or minor bleeding event  Time to first PLATO major bleeding event  Time to discontinuation of study medication due to any major bleeding event  Evaluation of non-serious AEs of interest, DAEs and SAEs