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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-004616-36
    Sponsor's Protocol Code Number:D5135C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-004616-36
    A.3Full title of the trial
    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)
    Studio di Fase IIIb multicentrico, randomizzato, in doppio cieco, a gruppi paralleli per comparare gli effetti del trattamento con ticagrelor rispetto a clopidogrel sul rischio di sviluppare morte cardiovascolare, infarto del miocardio ed ictus ischemico in pazienti con arteriopatia periferica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing cardiovascular effects of ticagrelor and clopidogrel in
    patients with Peripheral Artery Disease
    Studio di comparazione degli effetti cardiovascolari di ticagrelor e clopidogrel in pazienti con arteriopatia periferica
    A.3.2Name or abbreviated title of the trial where available
    EUCLID
    EUCLID
    A.4.1Sponsor's protocol code numberD5135C00001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTRAZENECA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 236 9933
    B.5.6E-mailinformation.center@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Brilique / Possia
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTICAGRELOR
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeAZD6140
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name PLAVIX
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers SNC
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLOPIDOGREL BISULFATE
    D.3.9.1CAS number 120202-66-6
    D.3.9.2Current sponsor codeClopidogrel Bisulfate
    D.3.9.4EV Substance CodeSUB12483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    peripheral artery disease
    Arteripatia Periferica
    E.1.1.1Medical condition in easily understood language
    claudication
    Claudicatio
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10047065
    E.1.2Term Vascular disorders
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the effect of long-term
    treatment with ticagrelor vs. clopidogrel on the event rate of the
    composite of CV death, MI and ischemic stroke in patients with
    established PAD.
    L’obiettivo primario dello studio è di confrontare l’effetto a lungo termine del trattamento con ticagrelor verso clopidogrel sulla percentuale di combinazione di eventi quali morte cardiovascolare, infarto del miocardio (MI), ed ictus ischemico in pazienti con accertata arteriopatia periferica
    E.2.2Secondary objectives of the trial
    To compare the effect of long-term treatment with ticagrelor vs.
    clopidogrel in patients with established PAD
    1 Composite of CV death and MI
    2 CV death
    3 MI
    4 All-cause mortality
    5 Composite of CV death, MI, and all cause stroke
    6 All revascularisation
    Confrontare l’effetto a lungo termine del trattamento con ticagrelor verso clopidogrel, in pazienti con accertata arteriopatia periferica:
    1. Combinazione di morte cardiovascolare ed infarto del miocardio
    2. Morte cardiovascolare
    3. Infarto del miocardio
    4. Tutte le cause di mortalità
    5. Combinazione di morte cardiovascolare, infarto del miocardio e tutte le cause di ictus
    6. Tutte le rivascolarizzazioni
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and Female patients 50 years old or older
    2. Symptomatic peripheral artery disease
    1) Pazienti di sesso maschile/ femminile &gt; 50 anni
    2) Sintomatologia PAD agli arti inferiori
    E.4Principal exclusion criteria
    1. Patients needing dual anti-platlet drug treatment before start of study
    2. Planned revascularisation or amputation
    3. Patients with known bleeding disorders
    4. Patients with a history of intracranial bleed
    5. Patients considered to be at risk of bradycardic events unless already
    treated with a permanent pacemaker
    1) Pazienti che necessitano di doppia terapia anti-piastrinica al momento di entrare nello studio.
    2) Rivascolarizzazione o amputazione pianificata
    3) Pazienti con disordini di sanguinamento noti
    4) Pazienti con storia di emorragie intracraniche
    5) Pazienti considerati a rischio di eventi di bradicardici a meno che non trattati con pacemaker permanente.
    E.5 End points
    E.5.1Primary end point(s)
    Any event after randomization from the composite of cardiovascular
    death, myocardial infarction and ischemic stroke
    Qualsiasi evento dalla randomizzazione
    dalla combinazione di eventi quali morte cardiovascolare, infarto del miocardio (MI) e isctus ischemico
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 37 months
    Approssimativamente fino a 37 mesi
    E.5.2Secondary end point(s)
    Composite of cardiovascular death and myocardial infarction after
    randomization
    Cardiovascular death after randomization
    Myocardial infarction after randomization
    All-cause mortality after randomization
    Cardiovascular death, myocardial infarction and all-cause stroke
    (ischaemic or haemorrhagic) after randomization
    All revascularisation after randomization
    Combinazione di eventi quali morte cardiovascolare e infarto del miocardio (MI) dopo la randomizzazione
    Combinazione di morte cardiovascolare ed infarto del miocardio
    2. Morte cardiovascolare dopo la randomizzazione
    3. Infarto del miocardio dopo la randomizzazione
    4. Tutte le cause di mortalità dopo la randomizzazione
    5. Combinazione di morte cardiovascolare, infarto del miocardio e tutte le cause di ictus dopo la randomizzazione
    6. Tutte le rivascolarizzazioni dopo la randomizzazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to approximately 37 months
    Approssimativamente fino a 37 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned32
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA260
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Chile
    China
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    Philippines
    Russian Federation
    Thailand
    Turkey
    Ukraine
    United States
    Vietnam
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    planned LSLV study completion date: 2016-01-07
    LSLV pianificata (data di conclusione dello studio): 07-01-2016
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months38
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months38
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6900
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4695
    F.4.2.2In the whole clinical trial 11500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    standard of care
    trattamento standard
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
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