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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732822

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Wrocław, Poland
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Zamość, Poland
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Łódź, Poland
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Łęczna, Poland
Romania
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Bacau, Romania
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Braila, Romania
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Brasov, Romania
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Bucharest, Romania
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Buzau, Romania
Research Site
Cluj Napoca, Romania
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Craiova, Romania
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Iasi, Romania
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Pitesti, Romania
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Sibiu, Romania
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Suceava, Romania
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Tg. Mures, Romania
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Timisoara, Romania
Russian Federation
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Arkhangelsk, Russian Federation
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Chelyabinsk, Russian Federation
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Ekaterinburg, Russian Federation
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Gatchina, Russian Federation
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Kazan, Russian Federation
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Moscow, Russian Federation
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Nizhnii Novgorod, Russian Federation
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Novosibirsk, Russian Federation
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Perm, Russian Federation
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Rostov-on-Don, Russian Federation
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Saint Petersburg, Russian Federation
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Saint-Petersburg, Russian Federation
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Saratov, Russian Federation
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Tomsk, Russian Federation
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Tver, Russian Federation
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Vladikavkaz, Russian Federation
Slovakia
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Bratislava, Slovakia
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Dunajska Streda, Slovakia
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Kosice, Slovakia
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Nitra, Slovakia
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Nove Zamky, Slovakia
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Poprad, Slovakia
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Presov, Slovakia
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Trnava, Slovakia
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Zilina, Slovakia
Spain
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Albacete, Spain
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Alcorcon, Spain
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Alicante, Spain
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Badalona, Spain
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Badalona(Barcelona), Spain
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Barcelona, Spain
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Boadilla del Monte, Spain
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Coruña, Spain
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Getafe, Spain
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Granada, Spain
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Hospitalet de Llobregat(Barcel, Spain
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Huelva, Spain
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Lérida, Spain
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Madrid, Spain
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Mallorca, Spain
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Manises, Spain
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Málaga, Spain
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Oviedo, Spain
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Sabadell, Spain
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Tarragona, Spain
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Toledo, Spain
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Valencia, Spain
Sweden
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Eksjö, Sweden
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Gävle, Sweden
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Göteborg, Sweden
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Karlstad, Sweden
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Malmö, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Västerås, Sweden
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Örebro, Sweden
Thailand
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Bangkok, Thailand
Research Site
Bangkoknoi, Thailand
Research Site
Khon Kaen, Thailand
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Songkla, Thailand
Turkey
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Ankara, Turkey
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Bursa, Turkey
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Istanbul, Turkey
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Izmir, Turkey
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Malatya, Turkey
Ukraine
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Donetck, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kharkov, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Uzhgorod, Ukraine
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Vinnitsa, Ukraine
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Zaporizhya, Ukraine
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Zaporizhzhya, Ukraine
United Kingdom
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Aberdeen, United Kingdom
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Birmingham, United Kingdom
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Bournemouth, United Kingdom
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Cambridge, United Kingdom
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Cheltenham, United Kingdom
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Dundee, United Kingdom
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Hull, United Kingdom
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Leeds, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Newcaslte upon TYNE, United Kingdom
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Worcester, United Kingdom
Vietnam
Research Site
Hanoi, Vietnam
Research Site
Hcmc, Vietnam
Research Site
Ho Chi Minh, Vietnam
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
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Instituto de Salud Publica de Chile
China: Ethics Committee
China: Ministry of Health
China: National Natural Science Foundation
China: Food and Drug Administration
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Japan: Foundation for Biomedical Research and Innovation
Japan: Institutional Review Board
Japan: Ministry of Education, Culture, Sports, Science and Technology
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ministry of Health
Mexico: National Council of Science and Technology
Mexico: National Institute of Public Health, Health Secretariat
Netherlands: Independent Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Medicines Evaluation Board (MEB)
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Philippines: Bureau of Food and Drugs
Philippines: Department of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Romania: Ministry of Public Health
Romania: National Medicines Agency
Romania: State Institute for Drug Control
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Sweden: Swedish National Council on Medical Ethics
Sweden: Swedish Research Council
Sweden: The National Board of Health and Welfare
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Thailand: Khon Kaen University Ethics Committee for Human Research
Thailand: Ministry of Public Health
Turkey: Ethics Committee
Turkey: Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Department of Health
United Kingdom: Food Standards Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
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:
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 April 21, 2014