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Trial record 1 of 73 for:    EUCLID
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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
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
  • 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 ]

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)
  Eligibility

Ages Eligible for Study:   50 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01732822

  Show 601 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01732822     History of Changes
Other Study ID Numbers: D5135C00001
2011-004616-36 ( EudraCT Number )
Study First Received: November 20, 2012
Last Updated: October 25, 2016

Keywords provided by AstraZeneca:
Peripheral artery disease Atherothrombotic events Atherosclerosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Clopidogrel
Ticlopidine
Ticagrelor
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

ClinicalTrials.gov processed this record on August 23, 2017