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    Summary
    EudraCT Number:2012-000997-53
    Sponsor's Protocol Code Number:RF-2009-1546106
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-07
    Trial 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 number2012-000997-53
    A.3Full title of the trial
    ANTIPLATELET TREATMENT FOR PREVENTION OF VASCULAR OUTCOMES IN PAD PATIENTS UNDERGOING PERIPHERAL REVASCULARIZATION.
    TRATTAMENTO ANTIPIASTRINICO NELLA PREVENZIONE DEGLI EVENTI VASCOLARI NEI PAZIENTI AFFETTI DA PAD SOTTOPOSTI A PROCEDURE DI RIVASCOLARIZZAZIONE PERIFERICA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ANTIPLATELET TREATMENT FOR PREVENTION OF VASCULAR OUTCOMES IN PAD PATIENTS UNDERGOING PERIPHERAL REVASCULARIZATION.
    TRATTAMENTO ANTIPIASTRINICO NELLA PREVENZIONE DEGLI EVENTI VASCOLARI NEI PAZIENTI AFFETTI DA PAD SOTTOPOSTI A PROCEDURE DI RIVASCOLARIZZAZIONE PERIFERICA.
    A.4.1Sponsor's protocol code numberRF-2009-1546106
    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 SponsorAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistero della Salute - Regione Toscana
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSapienza - Universita' di Roma, Policlinico Umberto I°
    B.5.2Functional name of contact pointUOC Medicina Interna C - TMC07
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number064461933
    B.5.5Fax number064461933
    B.5.6E-mailfrancesco.violi@uniroma1.it
    D. IMP Identification
    D.IMP: 1
    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 CARDIOASPIRIN*30CPR GAST 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Gastro-resistant 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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typesintesi
    D.IMP: 2
    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 PLAVIX*28CPR RIV 75MG
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 MONOSULFATE
    D.3.9.4EV Substance CodeSUB25469
    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 Yes
    D.3.11.13.1Other medicinal product typesintesi
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Will be enrolled in the study patients suffering from intermittent claudication in whom resulted ineffective both pharmacological and workout therapy- Will be considered eligible patients aged 40-80 inclusive, with an ankle-brachial index (ABI) <0.9 or > 1.3 at basal condition and diametrical arterial stenosis equal or superior to 50% vessel lumen, undergoing peripheral revascularization procedures.
    Pazienti affetti da claudicatio intermittens nei quali non sono efficaci né il trattamento farmacologico né la terapia basata sull’esercizio fisico. Saranno eleggibili se di età compresa tra i 40 e gli 80 anni, con un indice caviglia-braccio [ankle-brachial index (ABI)] < 0.9 o > 1.3 in condizioni di base e stenosi diametriche delle arterie pari o superiori al 50% del lume vasale, sottoposti a procedure di rivascolarizzazione periferica.
    E.1.1.1Medical condition in easily understood language
    Will be enrolled in the study patients reporting a reduced walking autonomy, because an arterial lower extremity circulation impairment.
    Saranno arruolati nello studio pazienti con ridotta autonomia di marcia a causa di alterazione della circolazione arteriosa degli arti inferiori.
    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 LLT
    E.1.2Classification code 10003209
    E.1.2Term Arteriopathy
    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
    To evaluate antiplatelet treatment resistance percentage, considering the residual platelet activity as superior to 70% using ADP or Arachidonic Acid in vitro aggregation tests.
    Valutare la percentuale di resistenza al trattamento antiaggregante piastrinico considerando come Attività piastrinica residua quella superiore al 70% usando o l’ADP o l’Acido Arachidonico (AA) come stimolo nei test di aggregazione piastrinica in vitro.
    E.2.2Secondary objectives of the trial
    To compare different platelet function test about sensitivity, specificity and future clinical events predictive values; To evaluate the relationship between oxidative stress indexes and platelet activation; To evaluate the antiplatelet treatment resistance role on future clinical events; To evaluate the platelet fuction test predictive role, seric thromboxane levels and oxidative stress indexes levels on future clinical events; To validate a both clinical and laboratory predicitive score to identify the recurrent thrombosis high risk patients; To verify the platelet function tests diffusion in the real world.
    Comparare i test di funzionalità piastrinica in termini di sensibilità,specificità,accuratezza e valori predittivi dei test sugli eventi clinici futuri; Valutare la relazione tra alcuni indici di stress ossidativo e l’attivazione piastrinica; Valutare il ruolo della resistenza al trattamento antiaggregante piastrinico sugli eventi clinici futuri; Valutare il ruolo predittivo dei differenti test di funzionalità piastrinica,del dosaggio del trombossano sierico e degli indici di stress ossidativo sugli eventi clinici futuri; Validare uno score basato su parametri clinici e di laboratorio,che permetta al clinico di identificare i pazienti ad altro rischio di trombosi ricorrente; Verificare la diffusione dei test di funzionalità piastrinica nel mondo reale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Intermittent claudication affected patients in whom resulted ineffective both pharmacological and workout therapy; Both gender aged 40-80 inclusive; ABI <0.9 or > 1.3; Diametrical arterial stenosis equal or superior to 50% vessel lumen.
    Pazienti con claudication intermittens non responsiva a terapia; Pazienti di entrambi i sessi di età compresa tra i 40 e gli 80 anni; ABI &lt;0.90 o &gt;1.3; Presenza di stenosi arteriose diametriche pari o superiori a 50% del lume.
    E.4Principal exclusion criteria
    Critical or acute limb ischemia affected patients; Patients underwent a previous revascularization procedure within 6 months to the enrollment.
    Pazienti con ischemia critica o acuta degli arti inferiori; Pazienti sottoposti a precedenti procedure di rivascolarizzazione entro 6 mesi dall'arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    The target vessels thrombosis absence.
    Assenza di trombosi dei vasi target.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days, 3 months, 6 months, 12 months.
    30 giorni, 3 mesi, 6 mesi, 12 mesi.
    E.5.2Secondary end point(s)
    The occurrence of a Major Adverse Cardiac Events.
    Evento avverso vascolare maggiore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 3 months, 6 months, 12 months.
    30 giorni, 3 mesi, 6 mesi, 12 mesi.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial1
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 205
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 205
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state410
    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)
    The study subjects, at the end of the study, will continue the normal and planned clinical-instrumental follow-up.
    I soggetti in studio, al termine della sperimentazione, continueranno il loro normale e previsto follow-up clinico-strumentale.
    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 Decision2012-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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