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Note: This record shows only 21 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: 16 December 2017
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 4, 2012
Target sample size: 13885
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01732822
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Argentina Brazil Bulgaria Canada Chile China Czech Republic Czechia
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: All
Health Condition(s) or Problem(s) studied
Peripheral Artery Disease
Intervention(s)
Drug: Clopidogrel
Drug: Ticagrelor
Primary Outcome(s)
Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke [Time Frame: From randomization to PACD, an average of 2.5 years]
Secondary Outcome(s)
ALI [Time Frame: From randomization to PACD, an average of 2.5 years]
All-cause Mortality [Time Frame: From randomization to PACD, an average of 2.5 years]
Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) [Time Frame: From randomization to PACD, an average of 2.5 years]
Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) [Time Frame: From randomization to PACD, an average of 2.5 years]
Composite of CV Death, MI, Ischemic Stroke, and ALI [Time Frame: From randomization to PACD, an average of 2.5 years]
CV Death [Time Frame: From randomization to PACD, an average of 2.5 years]
Lower Extremity Revascularization [Time Frame: From randomization to PACD, an average of 2.5 years]
MI [Time Frame: From randomization to PACD, an average of 2.5 years]
Secondary ID(s)
2011-004616-36
D5135C00001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available: Yes
Date Posted: 30/10/2017
URL: https://clinicaltrials.gov/ct2/show/results/NCT01732822
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