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

Phase 3

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT01732822
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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)

Study Timeline

• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-26
• Study Start: 2012-12-04
• Primary Completion: 2016-09-26
• Study Completion: 2016-09-26
• Results First Submitted: 2017-07-13
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-29
• Last Update Submitted: 2017-09-29
• Results First Posted: 2017-10-30
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13885

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
Clopidogrel	Clopidogrel	Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets

Primary Outcome Measures

Name	Time	Method
Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke	From randomization to PACD, an average of 2.5 years	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇻🇳 Hochiminh, Vietnam