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    The EU Clinical Trials Register currently displays   44132   clinical trials with a EudraCT protocol, of which   7324   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-005445-32
    Sponsor's Protocol Code Number:LA-II-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-03-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-005445-32
    A.3Full title of the trial
    The BLADE-PCI Trial (PHASE IIB LIPOSOMAL ALENDRONATE STUDY):
    Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Administration of a medication which can inhibit inflammation cells in patients with diabetes who are undergoing a procedure to open blocked blood vessels.
    A.3.2Name or abbreviated title of the trial where available
    BLADE-PCI
    A.4.1Sponsor's protocol code numberLA-II-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02645799
    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 SponsorBIOrest, Ltd.
    B.1.3.4CountryIsrael
    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 organisationTrium Clinical Consulting
    B.5.2Functional name of contact pointKathleen Weyns
    B.5.3 Address:
    B.5.3.1Street AddressPosthoornstraat 14
    B.5.3.2Town/ cityLier
    B.5.3.3Post code2500
    B.5.3.4CountryBelgium
    B.5.4Telephone number32473218484
    B.5.6E-mailkw@triumclinicalconsulting.com
    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.3.1Product nameLiposomal Alendronate
    D.3.2Product code LABR-312
    D.3.4Pharmaceutical form Solution for infusion
    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 INNSodium Alendronate
    D.3.9.1CAS number 121268-17-5
    D.3.9.2Current sponsor codeLABR-312
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PCI (percutaneous coronary intervention) for angina, silent ischemia or non-STEMI in patients with diabetes mellitus.
    E.1.1.1Medical condition in easily understood language
    Opening of blocked blood vessels in patients with diabetes mellitus.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10012654
    E.1.2Term Diabetic complications cardiovascular
    E.1.2System Organ Class 100000004860
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.2System Organ Class 100000004866
    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 of the BLADE-PCI trial is to assess the efficacy, dose response, and safety of LABR-312 (liposomal alendronate) administration given at the time of PCI (percutaneous coronary intervention) on the OCT (Optical Coherence Tomography) endpoint of in-stent NIH% (neo-intimal hyperplasia) obstruction at 9 months in patients with Diabetes Mellitus. All target lesions will be treated with the RESOLUTE Drug-Eluting Stent.
    E.2.2Secondary objectives of the trial
    Secondary OCT Endpoints evaluated at 9 months as measured by the OCT (Optical Coherence Tomography) core laboratory:
    • %NIH (neo-intimal hyperplasia)at MLA (minimal lumen area) site
    • MLA (minimal lumen area)
    • % area stenosis
    • % stent strut coverage

    Secondary Angiographic Endpoints evaluated at 9 months:
    • In-stent late loss
    • In-segment %DS (diameter stenosis)(within 5 mm margins proximal and distal to stent)
    • In-stent %DS (diameter stenosis)
    • In-segment late loss
    • In-stent late loss compared between the 3 doses of the study drug
    • In-stent binary restenosis (stenosis of >50% of the vessel diameter)
    • In-segment binary restenosis (stenosis of >50% of the vessel diameter)
    • In-stent MLD (minimum lumen diameter)
    • Length and patterns of angiographic restenosis (Mehran classification)

    Secondary Clinical Endpoints evaluated at 30 days, 9 months, and 1 year:
    • MACCE (major adverse cardiac and cerebrovascular events): defined as death, MI (myocardial infarction),
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient has medically treated diabetes mellitus
    2.Patient is eligible and has an indication for PCI with a drug eluting stent
    3.Patient presents with angina (stable or unstable), silent ischemia or NSTEMI
    4.The patient or legal guardian is willing and able to provide written informed consent and comply with follow-up visits and the testing schedule
    5.Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.25 mm to ≤4.2 mm and diameter stenosis ≥50% to <100%.
    E.4Principal exclusion criteria
    1.STEMI within 7 days of presentation to the first treating hospital
    2.PCI within the 24 hours prior to randomization.
    3.Cardiogenic shock
    4.Known left ventricular ejection fraction <30%.
    5.Relative or absolute contraindication to DAPT for 6 months
    6.Known allergy to the study stent components or protocol-required concomitant medications
    7.Subject is taking Bisphosphonates
    8.Women who are pregnant or breastfeeding
    9.Unprotected left main lesions >30% or left main intervention
    10.Primary PCI for STEMI
    11.Total occlusions
    12.Restenotic lesions
    E.5 End points
    E.5.1Primary end point(s)
    %NIH volume (NIH volume/stent volume × 100) at 9 months as measured by the OCT core laboratory (all doses pooled vs. placebo).

    (NIH= neointimal hyperplasia)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be evaluated at 9 months (+/- 2 weeks) after enrolment.
    E.5.2Secondary end point(s)
    Secondary OCT Endpoints evaluated at 9 months as measured by the OCT core laboratory:
    •%NIH (neointimal hyperplasia) at MLA (minimum lumen area) site
    •MLA (minimum lumen area)
    •% area stenosis
    •% stent strut coverage

    Secondary Angiographic Endpoints evaluated at 9 months:
    •In-stent late loss
    •In-segment %DS (diameter stenosis)(within 5 mm margins proximal and distal to stent)
    •In-stent %DS (diameter stenosis)
    •In-segment late loss
    •In-stent late loss compared between the 3 doses of the study drug
    •In-stent binary restenosis (stenosis of >50% of the vessel diameter)
    •In-segment binary restenosis (stenosis of >50% of the vessel diameter)
    •In-stent MLD (minimum lumen diameter)
    •Length and patterns of angiographic restenosis (Mehran classification)

    Secondary Clinical Endpoints evaluated at 30 days, 9 months, and 1 year:
    •MACCE (major adverse cardiac and cerebrovascular events): defined as death, MI, clinically driven TLR (target lesion revascularization)(repeat PCI or CABG), or stroke (major, minor) at 30 days, 9 months, and 1 year post procedure
    •Clinically driven TLR (target lesion revascularization): defined as re-intervention (PCI or CABG) due to stenosis of ≥50% at the level of the index-targeted lesion(s) (inside 5 mm proximal and distal to the implanted stent), by quantitative coronary angiography (QCA), with ischemic signs and/or symptoms at 30 days, 9 months, and 1 year post procedure
    •Clinically driven TVR (target vessel revascularization): defined as re-intervention (PCI or CABG) due to stenosis of ≥50% inside the targeted epicardial vessel, by QCA, with ischemic signs and/or symptoms at 30 days, 9 months, and 1 year post procedure
    •TVF (target vessel failure): defined as the composite of cardiac death, target vessel MI, or clinically driven TVR at 30 days, 9 months, and 1 year post procedure
    •TLF (target lesion failure): defined as the composite of cardiac death, target vessel MI, or clinically driven TLR at 30 days, 9 months, and 1 year post procedure
    •Target vessel-related MI (myocardial infarction)
    •Stroke (major, minor and transient ischemic attack)
    •All death at 30 days, 9 months, and 1 year post procedure
    •MI (myocardial infarction) at 30 days, 9 months, and 1 year post procedure
    •Composite endpoint of cardiac death or MI at 30 days, 9 months, and 1 year post procedure
    •Definite or probable Academic Research Consortium (ARC) defined stent thrombosis at 30 days, 9 months and 1 year post procedure
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secundary OCT and Angiographic endpoints will be evaluated at 9 months (+/- 2 weeks) after enrolment.
    The secundary clinical endpoints will be evaluated at 30 days (+/- 1week), 9 months (+/- 2 weeks) and 1 year (+/- 1 month) after enrolment.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    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 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 EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Poland
    United Kingdom
    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
    NA - the end of trial is considered as the last visit of the last subject undergoing the trial.
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 270
    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)
    Once the research is completed and the patient has exited from the study, all patients will continue to receive standard of care treatment and will be followed up routinely in accordance with the hospital policy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NA
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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