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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.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01732822
First received: November 20, 2012
Last updated: October 25, 2016
Last verified: October 2016
November 20, 2012
October 25, 2016
December 2012
September 2016   (Final data collection date for primary outcome measure)
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 ]
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.
Time from randomization to first occurrence of any event in the composite of cardiovascular death, myocardial infarction and ischemic stroke [ Time Frame: Up to 37 months ]
Complete list of historical versions of study NCT01732822 on ClinicalTrials.gov Archive Site
  • 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 randomization to occurrence of cardiovascular death [ Time Frame: Up to 40 months ]
  • Time from randomization to occurrence of myocardial infarction [ 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 composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) [ 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 lower extremity revascularization [ 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 randomization to first occurrence of any event in the composite of cardiovascular death and myocardial infarction [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of cardiovascular death [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of myocardial infarction [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of all-cause mortality [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of composite of cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) [ Time Frame: Up to 37 months ]
  • Time from randomization to occurrence of any revascularisation [ Time Frame: Up to 37 months ]
Not Provided
Not Provided
 
A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease
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)
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
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)
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Peripheral Artery Disease
  • Drug: Ticagrelor
    Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
    Other Name: Brilinta/Brilique
  • Drug: Clopidogrel
    Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
    Other Name: Plavix
  • Experimental: Ticagrelor
    Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
    Intervention: Drug: Ticagrelor
  • Active Comparator: Clopidogrel
    Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
    Intervention: Drug: Clopidogrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16415
September 2016
September 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
South Africa
 
NCT01732822
D5135C00001
2011-004616-36 ( EudraCT Number )
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: William R Hiatt, MD University of Colorado School of Medicine
Study Director: Peter Held, MD AstraZeneca
AstraZeneca
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP