A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease

Study Overview
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Brief Summary
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The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

Detailed Description
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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)

Official Title
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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)

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female patients 50 years old or older Symptomatic peripheral artery disease Exclusion Criteria: Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation Patients with known bleeding disorders Patients with a history of intracranial bleed Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br>Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets | Drug: Ticagrelor<br>* Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets<br>* Other names: Brilinta/Brilique;|
| Active Comparator: Clopidogrel<br>Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets | Drug: Clopidogrel<br>* Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke | Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of CV Death, MI, Ischemic Stroke, and ALI | Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | 
| CV Death | Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | 
| MI | Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | 
| All-cause Mortality | Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) | From randomization to PACD, an average of 2.5 years | 
| Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) | Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) | From randomization to PACD, an average of 2.5 years | 
| ALI | Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | 
| Lower Extremity Revascularization | Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | 
| Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) | Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) | From randomization to PACD, an average of 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease Atherothrombotic events Atherosclerosis