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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: November 20, 2012
Last updated: October 25, 2016
Last verified: October 2016
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

Condition Intervention Phase
Peripheral Artery Disease
Drug: Ticagrelor
Drug: Clopidogrel
Phase 3

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
Official 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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    However, the actual duration of the study will be based on accrual of the predetermined number of events (1364) for the primary endpoint, and therefore the study may be shorter or longer than 40 months The anticipated median duration is 32 months.

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Time from randomization to occurrence of cardiovascular death [ Time Frame: Up to 40 months ] [ Designated as safety issue: No ]
  • Time from randomization to occurrence of myocardial infarction [ Time Frame: Up to 40 months ] [ Designated as safety issue: No ]
  • Time from randomization to occurrence of all-cause mortality [ Time Frame: Up to 40 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time from randomisation to occurrence of ALI [ Time Frame: Up to 40 months ] [ Designated as safety issue: No ]
  • Time from randomisation to occurrence of lower extremity revascularization [ Time Frame: Up to 40 months ] [ Designated as safety issue: No ]
  • Time from randomisation to occurrence of any revascularisation (coronary, peripheral [limb, mesenteric, renal, carotid and other]) [ Time Frame: Up to 40 months ] [ Designated as safety issue: No ]

Enrollment: 16415
Study Start Date: December 2012
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
Drug: Ticagrelor
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
Other Name: Brilinta/Brilique
Active Comparator: Clopidogrel
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
Drug: Clopidogrel
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
Other Name: Plavix

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)

Ages Eligible for Study:   50 Years to 130 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01732822

  Show 601 Study Locations
Sponsors and Collaborators
Study Chair: William R Hiatt, MD University of Colorado School of Medicine
Study Director: Peter Held, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01732822     History of Changes
Other Study ID Numbers: D5135C00001  2011-004616-36 
Study First Received: November 20, 2012
Last Updated: October 25, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
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Argentina: Ministry of Health
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Netherlands: Independent Ethics Committee
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Netherlands: Medicines Evaluation Board (MEB)
Netherlands: Ministry of Health, Welfare and Sport
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Philippines: Bureau of Food and Drugs
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Vietnam: Ho Chi Minh City Health Service
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Peripheral artery disease Atherothrombotic events Atherosclerosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on January 14, 2017