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    Summary
    EudraCT Number:2010-023507-95
    Sponsor's Protocol Code Number:BASICS2010
    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:2012-10-11
    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 number2010-023507-95
    A.3Full title of the trial
    BASICS Trial (Basilar Artery International Cooperation Study Research Protocol)
    BASICS Trial (Basilar Artery International Cooperation Study Research Protocol): Studio randomizzato di sicurezza ed efficacia della terapia loco regionale intrarteriosa dopo trombolisi endovenosa nella occlusione acuta sintomatica della arteria basilare.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BASICS trial: Study research to evaluate the efficacy of additional intra-arterial therapy after intravenous thrombolysis in terms of favourable outcome in patients with an acute ischemic stroke caused by basilar artery occlusion.
    BASICS: studio clinico per valutare l'efficacia nel recupero clinico della aggiuntiva trombolisi intrarteriosa dopo trombolisi endovenosa nei pazienti con ictus ischemico causato dall'occlusione della arteria basilare
    A.3.2Name or abbreviated title of the trial where available
    BASICS trial
    BASICS trial
    A.4.1Sponsor's protocol code numberBASICS2010
    A.5.4Other Identifiers
    Name:NTR2617, EUCTR2010-023507-95-NLNumber:www.trialregister.nl, apps.who.int/trialsearch
    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 SponsorSt. Antonius Hospital
    B.1.3.4CountryNetherlands
    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 supportSt. Antonius Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNuovo Ospedale Civile Sant Agostino Estense
    B.5.2Functional name of contact pointStroke Unit
    B.5.3 Address:
    B.5.3.1Street AddressVia Giardini 1355
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41100
    B.5.3.4CountryItaly
    B.5.4Telephone number+390593962549
    B.5.5Fax number+390593962409
    B.5.6E-maila.zini@ausl.mo.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 ACTILYSE*IV FL 20MG+FL 20ML
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM IT.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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALTEPLASE
    D.3.9.1CAS number 105857-23-6
    D.3.9.2Current sponsor code026533024
    D.3.9.4EV Substance CodeSUB05378MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    The acute basilar artery occlusion (BAO) is associated with a rate of death or disability of almost 80%. Recently a prospective registry of patients with an acute BAO showed that the outcomes of patients treated with intravenous (IVT) or intra-arterial thrombolysis (IAT) were similar, underscoring the lack of a proven treatment modality in acute symptomatic BAO. This was a non-randomised study, hampered by the lack of a standard treatment protocol for all patients who entered the study
    L'occlusione acuta dell'arteria basilare è gravata da un tasso di mortalità e disabilità fino 80%, nonostante i progressi nella terapia dell'ictus. Un recente studio osservazionale non ha mostrato differenze significative tra il trattamento con Trombolisi Intrarteriosa (IAT) e Trombolisi standard endovenosa (IVT). Tale registro presentava i limiti di uno studio non randomizzato e della scarsa uniformità di popolazione e trattamento.
    E.1.1.1Medical condition in easily understood language
    Basilar artery occlusion has a rate of mortality and disability of 80%. No differences are known between the intravenous or intrarterial treatment to break the clot
    L'ictus da occlusione dell'arteria basilare ha un rischio di morte/disabilità dell'80%. Non sono note differenze tra la terapia che scioglie il coagulo somministrata in vena o arteria
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10004163
    E.1.2Term Basilar artery stenosis
    E.1.2System Organ Class 10029205 - Nervous system 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 main objective is to evaluate the efficacy of additional IA therapy after IV thrombolysis in patients with an acute ischemic stroke caused by basilar artery occlusion. A combined IV and IA approach was designed to offer rapid initiation of IV rt-PA, followed by additional titrated local IA therapy, to patients with moderate-to-severe strokes (NIHSS≥10). The goal was to achieve higher rates of early, successful reperfusion in a widely accessible manner. The efficacy will be measured in terms of favourable outcome at 90 days, defined as a modified Rankin score of 0-3.
    Valutare l'efficacia della terapia addizionale con trombolisi intra-arteriosa dopo la trombolisi endovenosa in pazienti con ischemia cerebrale acuta da occlusione dell'arteria basilare. L'approccio combinato IVT+IAT è stato disegnato per offrire un rapido inizio della terapia con IVT seguito da un addizionale IAT locale in pazienti con ictus di entità moderato-severa (NIHSS≥10). Lo scopo è di permettere una riperfusione precoce ed efficace in modo accessibile a svariati centri. Obiettivo principale è stabilire l'efficacia dell'approccio combinato IVT+IAT in termini di outcome favorevole a 90 giorni, definito come punteggio da 0 a 3 della scala di Rankin modificata (mRS).
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of a combined IV/IA approach with other clinical measures: 1) Excellent outcome defined as a mRS of 0-2; 2) mRS - not dichotomized; 3) EQ-5; 4) An improved early response to treatment as determined by a reduction in NIHSS by 5 points or more at 24 hours. - To evaluate the efficacy of a combined IV/IA approach with radiological measures: 1) A CT or MR angiography assessment of basilar artery patency at 24 hours 2) The volume of cerebral infarction as measured by a NCCT + CTA-SI at 24 hours. - To evaluate the safety of a combined IV/IA approach with the foolowing measures: 1) symptomatic intracranial haemorrhage; 2) intracranial haemorrhage contributing to patients’ death as determined by the study safety committee ; 3) overall mortality at 90 days. - To evaluate the safety and efficacy of mechanical devices as part of a combined IV/IA approach
    - Ulteriore valutazione dell'efficacia mediante parametri clinici: 1) outcome eccellente definito come mRS di 0-2; 2) valore assoluto del punteggio di mRS; 3) qualità della vita misurata con l'EQ-5D; 4) miglioramento clinico precoce definito come riduzione di 5 punti di NIHSS a 24 ore. - Valutazione dell'efficacia mediante parametri radiologici: 1) ricanalizzazione dell'arteria basilare ad un'angio TAC o angio-RMN a 24 ore; 2) il volume dell'infarto cerebrale alla TC a 24 ore. - Valutazione della sicurezza dell'approccio combinato IVT+IAT: 1) emorragia intracranica sintomatica 2)emorragia intracranica tale da contribuire al decesso del paziente, determinata da una commissione istituita per la sicurezza dello studio 3) mortalità globale a 3 mesi. - Valutazione della sicurezza e l'efficacia dei device meccanici utilizzati durante la IAT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Symptoms and signs compatible with ischemia in the basilar artery territory and an NIHSS ≥ 10 at time of randomization. - Basilar artery occlusion confirmed by CTA or MRA. - Age18 through 85 years - Initiation of IV rt-PA within 4.5 hours of estimated time of basilar artery occlusion.(Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms). - Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.
    - Segni e sintomi compatibili con ischemia nel territorio di irrorazione dell'arteria basilare e NIHSS&gt;10 - Occlusione dell'arteria basilare confermata dalla angioTAC o dalla angioRM - Età compresa tra 18 e 85 anni - L'inizio della IVT con rt-PA deve essere possibile entro 4,5 ore dal tempo stimato per l'occlusione dell'arteria basilare, definito come la comparsa acuta dei sintomi che hanno portato alla diagnosi clinica di chiusura dell'arteria basilare o dall'ultimo momento in cui il paziente è stato visto in salute prima dell'esordio dei sintomi. - L'inizio della IAT deve essere possibile entro 6 ore dal tempo stimato per l'occlusione dell'arteria basilare
    E.4Principal exclusion criteria
    • Pre-existing dependency with mRankin ≥3. • Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission. • Patients who require hemodialysis or peritoneal dialysis. • Other serious, advanced, or terminal illness. • Any other condition that the investigator feels would pose a significant hazard to the patient if IA therapy is initiated. • Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days). • Informed consent is not or cannot be obtained. • Lesion consistent with hemorrhage of any degree. • Significant cerebellar mass effect or acute hydrocephalus. • Bilateral extended brainstem ischemia.
    - Scarsa autonomia preesistente definita come mRS ≥3. - Donne consapevoli di essere gravidanza o durante l'allattamento oppure positività al test di gravidanza in ingresso - Pazienti che necessitano di terapia dialitica ematica o peritoneale - Altre patologie gravi o terminali - Qualsiasi condizione clinica che, a giudizio dell'investigatore, pone a rischio il paziente durante la procedura IAT - Concomitante partecipazione ad altri studi sperimentali su farmaci (il paziente non può iniziare altri agenti sperimentali nei 90 giorni successivi al trattamento) - Il consenso informato non è ottenibile - Presenza alla TC di emorragia di qualsiasi entità - Presenza alla TC di significativo effetto massa cerebellare o di idrocefalo acuto - Presenza alla TC di ischemia bilaterale estesa del troncoencefalo
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is favourable outcome at 90 days, defined as a modified Rankin score of 0-3, in patients with an acute ischemic stroke caused by basilar artery occlusion. Secondary analysis will compare the outcome in the following pre-defined subgroups: patients with a baseline NIHSS of 10 -19, and those with a baseline NIHSS of ≥ 20.
    Endpoint primario è l'outcome favorevole a 90 giorni, definito come mRS da 0 a 3 in pazienti con ictus di entità moderato-severa da occlusione dell'arteria basilare. Verrà svolta un'analisi secondaria per paragonare l'outcome a tre mesi nei due seguenti sottogruppi: 1) pazienti con NIHSS in ingresso pari a 10-19 e 2) pazienti con NIHSS in ingresso >20.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated by a blinded examiner at 3 months +/- 14 days with a telephone interview aimed to assess the mRS.
    L'endopoint primario verrà valutato a 3 mesi +/- 14 giorni da un esaminatore in cieco, mediante intervista telefonica per misurazione della scala Rankin modificata
    E.5.2Secondary end point(s)
    - Excellent outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-2. - Modified Rankin Score – not dichotomized. - National Institutes of Health Stroke Scale (NIHSS – acute assessment scale) post-IVT, at 24 +/- 6 hours post treatment, at 7 +/- 1 days or at discharge. - Recanalization at 24± 6 hours, by CT angiography. - Volume of cerebral infarction on a non-contrast CT (NCCT) scan. - Symptomatic intracranial hemorrhage at 24± 6 hours CT imaging. - Mortality at 90 days. - EQ-5D (quality of life) at 90 days and at 12 months
    - Outcome eccellente a 3 mesi definito come mRS di 0-2 - Punteggio assoluto, non suddiviso in categorie; alla mRS - NIHSS dopo l'IVT, a 24+/-6 ore e a 7+/-1 giorno dal trattamento - Ricanalizzazione dell'arteria basilare all'angio TAC a 24± 6 ore dal trattamento - Volume dell'infarto cerebrale nella TAC a 24± 6 ore dal trattamento - Emorragia intracranica sintomatica alla TAC a 24± 6 ore dal trattamento - Mortalità a 3 mesi - EQ-5D (qualità della vita) a 3 e 12 mesi
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immediately after the IVT the NIHSS will be quantified. At 24± 6 hours the NIHSS will be quantified and the patient will undergo a non-contrast CT (NCCT) scan and a CT angiography. At 7±1 days the NIHSS will be quantified. At 30±7 days the mRS will be quantified by a telephone interview. At 90±14 days the mRS and the EQ-5D will be quantified by a telephone interview. At 12 mounths ±14 days he mRS and the EQ-5D will be quantified by a telephone interview.
    Immediatamente dopo la IVT verrà quantificato l'NIHSS. A 24± 6 ore verranno effettuati l'esame clinico con stima dell'NIHSS e una CT con sequenze angioTC (o RM con sequenze angioRM) A 7±1 giorni verrà effettuato l'esame clinico con stima dell'NIHSS A 30±7 giorni verrà misurata la mRS mediante intervista telefonica A 90±14 giorni verranno misurati la mRS e l' EQ-5D mediante intervista telefonica A 12 mesi ±14 giorni verranno misurati la mRS e l' EQ-5D mediante intervista telefonica
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Appoccio combinato IVT+IAT contro la sola IVT
    Combined approach with IVT+IAT versus IVT alone
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-10-11. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with severe dysarthria or vigilance alteration due to the acute stroke
    Pazienti con grave disartria o alterazione della vigilanza secondarie all'ictus
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 750
    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)
    After the treatment all patients will be admitted to Intensive or Sub-intensive Department (Stroke Unit) according to the current guidelines for the treatment of stroke.
    Dopo il trattamento trombolitico tutti i pazienti verranno ricoverati in terapia intensiva o subintensiva (Stroke Unit) per monitoraggio e trattamento intensivo in accordo con le linee guida sull'ictus acuto.
    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 Decision2012-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-02
    P. End of Trial
    P.End of Trial StatusOngoing
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