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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01732822
First received: November 20, 2012
Last updated: February 19, 2014
Last verified: February 2014
  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
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 37 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomization to first occurrence of any event in the composite of cardiovascular death and myocardial infarction [ Time Frame: Up to 37 months ] [ Designated as safety issue: No ]
  • Time from randomization to occurrence of cardiovascular death [ Time Frame: Up to 37 months ] [ Designated as safety issue: No ]
  • Time from randomization to occurrence of myocardial infarction [ Time Frame: Up to 37 months ] [ Designated as safety issue: No ]
  • Time from randomization to occurrence of all-cause mortality [ Time Frame: Up to 37 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 37 months ] [ Designated as safety issue: No ]
  • Time from randomization to occurrence of any revascularisation [ Time Frame: Up to 37 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15328
Study Start Date: September 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor Drug: Ticagrelor
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
Other Name: Brilinta/Brilique
Active Comparator: Clopidogrel 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 and older
Genders Eligible for Study:   Both
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 617 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01732822     History of Changes
Other Study ID Numbers: D5135C00001, EudraCT number 2011-004616-36
Study First Received: November 20, 2012
Last Updated: February 19, 2014
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Keywords provided by AstraZeneca:
Peripheral artery disease Atherothrombotic events Atherosclerosis

Additional relevant MeSH terms:
Myocardial Infarction
Peripheral Arterial Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Clopidogrel
Ticlopidine
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014