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    The EU Clinical Trials Register currently displays   36348   clinical trials with a EudraCT protocol, of which   5989   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-000658-27
    Sponsor's Protocol Code Number:D5130C05262
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-29
    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 ConcernedGreece - EOF
    A.2EudraCT number2006-000658-27
    A.3Full title of the trial
    A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS)[PLATO – A Study of PLATelet inhibition and Patient Outcomes]
    A.3.2Name or abbreviated title of the trial where available
    PLATO
    A.4.1Sponsor's protocol code numberD5130C05262
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.2Product code AZD6140 90 mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameclopidogrel
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule, hard
    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
    non-ST and ST elevation acute coronary syndromes (ACS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level HLT
    E.1.2Classification code 10011085
    E.1.2Term Ischaemic coronary artery 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 this study is to test that AZD6140 is superior to clopidogrel for prevention of vascular events (death from vascular causes, MI, stroke) in patients with non-ST or ST elevation acute coronary syndromes (ACS).
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of AZD6140 compared to clopidogrel.
    - To assess the efficacy and safety of AZD6140 and clopidogrel in those patients
    undergoing coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) during the study.
    - To assess the occurrence of arrhythmic episodes detected by Holter monitoring during the initial period after randomization and at one month.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ECG substudy (same date as main study protocol)
    Objectives: To assess whether ST-T changes at hospital entry modulate AZD6140 treatment effect. To analyse whether ST changes in combination with biomarkers improve patient risk stratification over biomarkers alone. To assess differences between AZD6140 and clopidogrel treatment on ECG patterns at hospital discharge.

    Blood core substudy (same date as main study protocol)
    Objectives: To follow biomarkers over time and identify differences between AZD6140 and clopidogrel treated groups. To find correlations between clinical outcomes in these groups and biomarker levels at hospital entry, and at discharge or at one month. To assess the influence of the genetic constitution of AZD6140 treated patients on clinical outcomes and biomarker levels. To employ integrated proteomic and metabolomic and cellular analyses as candidate and discovery biomarkers for predicting clinical outcomes and drug safety. To investigate whether advanced biomarkers can predict drug safety and efficacy. To determine the prognostic value of advanced biomarkers.

    Angiography substudy (same date as main study protocol)
    Objective: investigate if the use of AZD6140 will be associated with further improvements in flow and perfusion on coronary angiography in the setting of ACS.

    Health economics and quality of life substudy (same date as main study protocol)
    Objectives: to estimate the incremental cost effectiveness ratio of AZD6140 compared to clopidogrel in patients with ACS.

    Genetic research (same date as main study protocol)
    Objectives: To obtain DNA samples for future exploratory research on the effects of genetic polymorphisms on i) the response to AZD6140 and clopidogrel, ii) the disposition of AZD6140 and clopidogrel and iii) the susceptibility to and prognosis of ACS under study

    Pulmonary substudy (Amendment 3)
    The primary objective of this pulmonary substudy is to evaluate the effects of AZD6140 and in comparison with clopidogrel on FEV1 (forced expiratory volume in 1 second) after completion of study treatment.
    Secondary objectives are:
    1. To compare the effects of AZD6140 and clopidogrel on FEV1 after one month of treatment and one month after discontinuation of treatment
    2. To compare the effects of AZD6140 and clopidogrel on other measures of pulmonary function (including other spirometric measures, lung volumes, oxygen saturation, diffusing capacity).

    E.3Principal inclusion criteria
    1. Index event of non-ST or ST segment elevation ACS. The patient should be hospitalised for chest pain and potential ACS and the onset of the most recent cardiac ischaemic symptoms of the index event must occur within the 24 hours before randomisation and be documented by cardiac ischaemic symptoms of ≥10 minutes duration at rest AND (i, ii, or iii):

    i) Persistent ST segment elevation ≥1mm (0.1 mV) in 2 or more contiguous leads and primary PCI planned
    OR
    ii) New or presumed new left bundle branch block (LBBB) and primary PCI planned
    OR
    iii) Cardiac ischaemic symptoms of ≥10 minutes duration at rest and at least 2 of the following 3 criteria (A-C):

    A) ST segment changes on ECG indicative of ischaemia
    B) Positive biomarker (Troponin I or -T or CK-MB) evidence of myocardial necrosis
    C) Having at least one of the following risk factors: Aged 60 or over, Previous MI or CABG, Known multi-vessel coronary artery disease (CAD), Previous ischaemic stroke, TIA, carotid stenosis, or cerebral revascularisation, Diabetes mellitus, Peripheral arterial disease, Chronic renal dysfunction

    2. Provision of signed informed consent form.
    3. Male or female aged at least 18 years
    4. Females of child-bearing potential who are willing to use 2 methods of contraception.
    E.4Principal exclusion criteria
    1. Contraindication or other reason that clopidogrel or AZD6140 should not be administered.
    2. Index event is a complication of PCI
    3. Patient has undergone PCI after the index event and before the first dose of study treatment
    4. Oral anticoagulation therapy that cannot be stopped
    5. Fibrinolytic therapy in the 24 hours prior to randomisation, or planned fibrinolytic
    treatment following randomisation
    6. Increased risk of bradycardic events (e.g. Known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker) The DSMB will review the holter data in this study to assess the need to continue with this exclusion.
    7. Patient requires dialysis
    8. Known, clinically important thrombocytopenia
    9. Known, clinically important anaemia
    10. Participation in another investigational drug or device study in the last 30 days
    11. Pregnancy or lactation
    12. Concomitant oral or intravenous therapy with strong CYP 3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study
    13. Any other condition which in the opinion of the investigator, may either put the patient at risk or influence the result of the study
    14. Involvement in the planning and conduct of the study
    15. Previous enrolment or randomisation of treatment in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    Time to the first occurrence of any event from the composite of death from vascular causes(*), myocardial infarction and stroke.
    (*): Death from vascular causes includes CV deaths, cerebrovascular deaths, and any other death for which there was no clearly documented non-vascular cause.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life - Patient reported outcomes
    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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1000
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of study is defined as date of database lock which is the timepoint after which no patient will be exposed to study-related activities.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10000
    F.4.2.2In the whole clinical trial 18000
    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 Decision2007-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-20
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