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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 November 2016
Main ID:  NCT01732822
Date of registration: 20/11/2012
Prospective Registration: Yes
Primary sponsor: AstraZeneca
Public title: A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease EUCLID
Scientific title: 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)
Date of first enrolment: December 2012
Target sample size: 16415
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01732822
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Phase:  Phase 3
Countries of recruitment
Argentina Brazil Bulgaria Canada Chile China Czech Republic France
Germany Hungary Italy Japan Korea, Republic of Mexico Netherlands Philippines
Poland Romania Russian Federation Slovakia South Africa Spain Sweden Thailand
Turkey Ukraine United Kingdom United States Vietnam
Contacts
Name:   Peter Held, MD
Address: 
Telephone:
Email:
Affiliation:  AstraZeneca
Name:   William R Hiatt, MD
Address: 
Telephone:
Email:
Affiliation:  University of Colorado School of Medicine
Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: 130 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Peripheral Artery Disease
Intervention(s)
Drug: Clopidogrel
Drug: Ticagrelor
Primary Outcome(s)
Time from randomization to first occurrence of any event in the composite of cardiovascular death, myocardial infarction and ischemic stroke [Time Frame: Up to 40 months]
Secondary Outcome(s)
Time from randomisation to first occurrence of any event in the composite of CV death, MI, ischemic stroke and ALI [Time Frame: Up to 40 months]
Time from randomisation to occurrence of ALI [Time Frame: Up to 40 months]
Time from randomisation to occurrence of any revascularisation (coronary, peripheral [limb, mesenteric, renal, carotid and other]) [Time Frame: Up to 40 months]
Time from randomisation to occurrence of lower extremity revascularization [Time Frame: Up to 40 months]
Time from randomization to occurrence of all-cause mortality [Time Frame: Up to 40 months]
Time from randomization to occurrence of cardiovascular death [Time Frame: Up to 40 months]
Time from randomization to occurrence of composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) [Time Frame: Up to 40 months]
Time from randomization to occurrence of myocardial infarction [Time Frame: Up to 40 months]
Secondary ID(s)
2011-004616-36
D5135C00001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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