A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease (EUCLID)
This study is currently recruiting participants.
Verified December 2012 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01732822
First received: November 20, 2012
Last updated: December 21, 2012
Last verified: December 2012
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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: | 11500 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 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
Show 503 Study Locations
Contacts
| Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Show 503 Study LocationsSponsors 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: | December 21, 2012 |
| 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 May 16, 2013