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    Summary
    EudraCT Number:2013-002799-42
    Sponsor's Protocol Code Number:CAPstatin2013
    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:2013-12-17
    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 number2013-002799-42
    A.3Full title of the trial
    Statins in the prevention of myocardial damage in pneumonia
    Le statine nella prevenzione del danno miocardico associato a polmonite
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of cardiovascular events in in patients with pneumonia
    La prevenzione degli eventi cardiovascolari in pazienti con polmonite.
    A.4.1Sponsor's protocol code numberCAPstatin2013
    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 SponsorDipartimento di Medicina Interna e Specialità Mediche - Policlinico Umberto I - Sapienza Università 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 supportDipartimento di Medicina Interna e Specialità Mediche - Sapienza Università di Roma
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Medicina Interna e Specialità Mediche - Policlinico Umberto I - Sapienza Università di Roma
    B.5.2Functional name of contact pointI Clinica Medica
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico 155
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number+39064461933
    B.5.5Fax number+390649970893
    B.5.6E-mailmedvioli@gmail.com
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBayer S.p.A
    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.3.1Product nameaspirin
    D.3.4Pharmaceutical form
    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 INNaspirin
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    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 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 Torvast
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Italia S.r.l.
    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.3.1Product nameatorvastatin
    D.3.4Pharmaceutical form
    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 INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients hospitalized with community-acquired pneumonia
    Polmonite acquisita in comunità
    E.1.1.1Medical condition in easily understood language
    Pneumonia
    Polmonite
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim of the study is to optimize antithrombotic therapy in the acute phase of community-acquired pneumonia, a condition associated to high cardiovascular risk.
    We will evaluate the effectiveness of atorvastatin 40 mg plus aspirin 100 mg vs. aspirin 100 mg daily in preventing cardiovascular events and myocardial injury in patients hospitalized for community-acquired pneumonia.
    Ottimizzare la terapia antitrombotica nella fase acuta della polmonite, condizione associata ad alto rischio cardiovascolare. In particolare sarà valutata l'efficacia di una terapia con 40 mg/die di atorvastatina + 100 mg aspirina vs. 100 mg aspirina nel prevenire gli eventi cardiovascolari e il danno miocardico in pazienti ospedalizzati per polmonite.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients hospitalized of community-acquired pneumonia
    Pazienti ospedalizzati per polmonite acquisita in comunità
    E.4Principal exclusion criteria
    • Patients already treated with statins
    • Health Care—Associated Pneumonia
    • pneumonia due to immunodeficiency syndromes (congenital or acquired)
    • presence of neoplasms
    • chronic inflammatory diseases
    • patients considered at high risk of bleeding (liver disease, chronic renal failure with glomerular filtration rate <30 mg / dl)
    • age less than 18 years
    • Pazienti già trattati con statine
    • presenza di caratteristiche anamnestiche suggestive di polmonite nosocomiale
    • polmonite legate ad immunodeficienza (sindromi da immunodeficienza congenite o acquisite)
    • presenza di neoplasie
    • presenza di malattie infiammatorie croniche
    • pazienti considerati ad alto rischio di sanguinamento (epatopatia, insufficienza renale cronica con FG < 30 mg/dl)
    • età minore di 18 anni
    E.5 End points
    E.5.1Primary end point(s)
    Primary endopoint will be the first occurence of one of the following cardiovascular events: acute myocardial infarction, stroke, cardiovascular death, new or worsening heart failure, new or worsening arrhythmias.
    Endpoint primario sarà l’insorgenza di uno dei seguenti eventi cardiovascolari: infarto acuto del miocardio, stroke, morte cardiovascolare, insorgenza di scompenso cardiaco o peggioramento di uno scompenso cardiaco pre-esistente, insorgenza di nuove aritmie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 6, 12, 18, 24 mesi.
    1, 6, 12, 16, 24 months.
    E.5.2Secondary end point(s)
    1) Intra-hospital myocardila injury assessed by high-sensitivity cardiac T Troponin within the first 72 hours from hospital admission.
    2) Intra-hospital worsening of the ejection fraction assessed by 2D-echocardiogram.
    3) Intra-hospital worsening of the endothelial function assessed by brachial artery ultrasound (flow-mediated dilatation)
    4) Intra-hospital increase of biomarkers of platelet activation (urinary and serum thromboxane), inflammation (hs-CRP) and oxidative stress (sNOX2-dp, urinary and serum isoprostanes)
    1) Danno miocardico precoce evidenziato dal rilascio di troponine T ad alta sensibilità durante le prime 72 ore dal ricovero per CAP.
    2) Peggioramento della frazione di eiezione valutata con l’ecocardiogramma durante il ricovero.
    3) Peggioramento della funzione endoteliale valutata con gli ultrasuoni (FMD o brachial index) durante il ricovero.
    4) Aumento dei markers di attivazione piastrinica (trombossano sierico e urinario), infiammatori (hs-CRP) e di stress ossidativo (sNOX2-dp, isoprostani sierici e urinari) durante il ricovero
    E.5.2.1Timepoint(s) of evaluation of this end point
    Echocardiogram and brachial artery index (FMD assessed by ultrasound) will be assessed at hospital admission and hospital discharge.
    High-sensitivity Troponin T will be measured at baseline and after 12, 24, 36 and 72 hours from hospital admission.
    The other biomarkers will be measured at hospital admission and hospital discharge.
    L'ecocardiogramma e l'FMD misurato con gli ultrasuoni sarà misurato durante il ricovero all'ingresso e alla dimissione.
    la troponina T ad alta sensibilità sarà misurata di base e a 12, 24, 36 e 72 ore dall'ingresso in ospedale.
    Gli altri biomarcatori saranno misurati durante il ricovero all'ingresso e alla dimissione.
    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 No
    E.6.5Efficacy No
    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 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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Solo aspirina senza atorvastatina
    Aspirin alone (without atorvastatin)
    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 concerned3
    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
    The end of the trial will correspond with the last visit of the last patient included in the study.
    La conclusione dello studio corrisponderà con l'ultima visita dell’ultimo paziente incluso nello studio stesso.
    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.1.1.1In 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state210
    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)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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