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    Summary
    EudraCT Number:2012-001952-20
    Sponsor's Protocol Code Number:NCT:01555658
    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:2012-12-19
    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 number2012-001952-20
    A.3Full title of the trial
    BIVALIRUDIN PLUS STENTING IN lONG LESION TO AVOID PERIPROCEDURAL MYOCARDIAL NECROSIS TRIAL. BILLION TRIAL
    BIVALIRUDIN PLUS STENTING IN lONG LESION TO AVOID PERIPROCEDURAL MYOCARDIAL NECROSIS TRIAL. BILLION TRIAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    UTILIZZO DELLA BIVALIRUDINA PIU' IMPIANTO DI STENT IN LESIONI CORONARICHE LUNGHE NEL PREVENIRE LA MIONECROSI PERIPROCEDURALE
    UTILIZZO DELLA BIVALIRUDINA PIU' IMPIANTO DI STENT IN LESIONI CORONARICHE LUNGHE NEL PREVENIRE LA MIONECROSI PERIPROCEDURALE
    A.3.2Name or abbreviated title of the trial where available
    BILLION TRIAL
    BILLION TRIAL
    A.4.1Sponsor's protocol code numberNCT:01555658
    A.5.4Other Identifiers
    Name:BILLION TRIALNumber:BILLION TRIAL
    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 supportPOLICLICNICO UMBERTO I
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPOLICLINICO UMBERTO I
    B.5.2Functional name of contact pointU.O. EMODINAMICA
    B.5.3 Address:
    B.5.3.1Street AddressVIA DEL POLICLINICO 155
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code001561
    B.5.3.4CountryItaly
    B.5.4Telephone number0649979044
    B.5.5Fax number0649979047
    B.5.6E-mailrino.sardella@uniroma1.it
    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 ANGIOX*EV 10F 250MG
    D.2.1.1.2Name of the Marketing Authorisation holderTHE MEDICINES COMPANY (IT.)Srl
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIVALIRUDIN
    D.3.9.1CAS number 128270-60-0
    D.3.9.4EV Substance CodeSUB05862MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number250
    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 typeANTITROMBINICO DIRETTO
    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 EPARINA BMS*1FL 5ML 5000UI/ML
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB Srl
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPARIN
    D.3.9.1CAS number 9005-49-6
    D.3.9.4EV Substance CodeSUB02475MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number60
    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 typeantitrombotico
    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 with coronary artery disease after stent implantation in coronary long lesions (>25 mm) and undergoing non urgent percutaneous coronary intervention.
    Pazienti con malattia coronarica caratterizzata da stenosi di lunghezza superiore a 25 mm e rivascolarizzati mediante angiopolastica coronarica percutanea elettiva ed impianto di stent.
    E.1.1.1Medical condition in easily understood language
    patients with coronary artery disease after stent implantation in coronary long lesions (>25 mm) and undergoing non urgent percutaneous coronary intervention.
    Pazienti con malattia coronarica caratterizzata da stenosi di lunghezza superiore a 25 mm e rivascolarizzati mediante angiopolastica coronarica percutanea elettiva ed impianto di stent.
    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 PT
    E.1.2Classification code 10011089
    E.1.2Term Coronary artery stenosis
    E.1.2System Organ Class 10007541 - Cardiac 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 assess the safety and efficacy of routine usage of the bivalirudin vs Heparin to avoid periprocedural myocardial necrosis.
    Valutare la sicurezza el'efficacia dell'uso routinario della Bivalirudina in comparazione con quello dell'Eparina non frazionata in sala di emodinamica per ridurre l'incidenza della necrosi miocardica periprocedurale.
    E.2.2Secondary objectives of the trial
    Rate of major adverse cerebro-cardiovascular events, major and minor bleeding at 1, 6 and 12 months.
    valutare l'incidenza degli eventi cardiovascolari e cerebrovascolari maggiori, sanguinamenti maggiori e minori dopo 1,6 e 12 mesi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    sign informed consent; age>18 years; patients with stable or unstable angina pectoris; de novo lesion with total lenght >25 mm;
    firma del consenso informato, età &gt;18 anni, pazienti con angina pectoris stabile o instabile; stenosi coronarica &gt;25 mm di lunghezza;
    E.4Principal exclusion criteria
    serum creatinine>2,5 mg/dl; pregnancy; ST elevation myocardial infarction; ongoing serious bleeding; previous stroke;Hemodynamic instability
    creatinina &gt;2,5 mg/dl; gravidanza; infartoi miocardico con ST sopralivellato; sanguinamenti massivi in atto; pregressi stroke; instabilità emodinamica
    E.5 End points
    E.5.1Primary end point(s)
    to value the incidence of periprocedural myonecrosis defined as a peak postprocedural CK.MB elevation>1 time the upper limit of normal, alone or associated with chest pain or ST segment or T wave abnormalities, in patients undergoing non urgent percutaneous myocardial revascularization.
    valutare l'incidenza della necrosi miocardica periprocedurale definita come un rialzo della CK-MB>1 volta il limite del normale, associata o meno ad elevazione del segmento ST o a dolore toracico o ancora ad inversione delle onde T, in pazienti sottoposti a rivascolarizzazione miocardica percutane elettiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6, 12 and 24 hours after the rivascolarization procedure.
    6, 12 e 24 ore dopo la procedura di rivascolarizzazione.
    E.5.2Secondary end point(s)
    Rate of major adverse cerebro-cardiovascular events, major and minor bleeding at 1, 6 and 12 months.
    valutare l'incidenza degli eventi cardiovascolari e cerebrovascolari maggiori, sanguinamenti maggiori e minori dopo 1,6 e 12 mesi
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 6 and 12 months
    30 giorni, 6 e 12 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 Yes
    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 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) 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 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) 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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years0
    E.8.9.1In the Member State concerned months24
    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 months24
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 154
    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 state204
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 204
    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)
    nothing
    nessuna
    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 Decision2012-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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