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    Summary
    EudraCT Number:2011-001006-10
    Sponsor's Protocol Code Number:Revacept/CS/02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-28
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2011-001006-10
    A.3Full title of the trial
    REVACEPT, AN INHIBITOR OF PLATELET ADHESION IN SYMPTOMATIC CAROTID STENOSIS: A PHASE II, MULTICENTRE; RANDOMISED, DOSE-FINDING, DOUBLE-BLIND AND PLACEBO-CONTROLLED SUPERIORITY STUDY WITH PARALLEL GROUPS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    REVACEPT, AN INHIBITOR OF PLATELET ADHESION IN SYMPTOMATIC CAROTID STENOSIS: A PHASE II, MULTICENTRE; RANDOMISED, DOSE-FINDING, DOUBLE-BLIND AND PLACEBO-CONTROLLED SUPERIORITY STUDY WITH PARALLEL GROUPS
    A.4.1Sponsor's protocol code numberRevacept/CS/02
    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 SponsoradvanceCOR GmbH
    B.1.3.4CountryGermany
    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 supportadvanceCOR GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationadvanceCOR GmbH
    B.5.2Functional name of contact pointProf. Dr. med. Götz Münch
    B.5.3 Address:
    B.5.3.1Street AddressFraunhoferstr. 9a
    B.5.3.2Town/ cityMartinsried
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number0049892000 20410
    B.5.5Fax number0049892000 20420
    B.5.6E-mailmuench@advancecor.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 nameRevacept
    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 INNPR-15
    D.3.9.2Current sponsor codeRevacept
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.4
    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 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
    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
    Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks, amaurosis fugax or stroke and who presenting with microembolic signals.
    E.1.1.1Medical condition in easily understood language
    Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks, amaurosis fugax or stroke and who presenting with microembolic signals.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10007687
    E.1.2Term Carotid 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
    Efficacy objectives are:
    • Assessment of incidence of microembolic signals (MES) by transcranial Doppler (TCD) examination (before and after treatment)
    • Rate of MES per hour (before and after treatment)
    • Cerebral lesion analysis by DWI-NMR
    • Assessment of neurological status (NIH Stroke Scale)
    • Clinical endpoints will be summarised cumulatively i.e. before treatment, after treatment, at 3 months and at 12 months. The following endpoints will be recorded:
    o Rate of all cause death
    o Rate of stroke-related death
    o Any TIA, amaurosis fugax or stroke including haemorrhagic stroke
    • Assessment of cardiovascular outcome including myocardial infarction and re-intervention up to 3 and 12 months
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria
    • Male and female patients aged >18 years
    • Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography)
    Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria
    • TIA, amaurosis fugax or stroke within the last 30 days
    E.4Principal exclusion criteria
    • NIHSS score > 18
    • Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR)
    • Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves)
    • History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug
    • History or evidence of thrombocytopenia (<30.000/µl), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thrompoplastin time (aPTT))
    • Thrombolysis within the last 48 hours
    • Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis
    • Oral anticoagulation or dual anti-platelet therapy with aspirin or clopidogrel and other P2Y inhibitors at screening (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat)
    • Sustained hypertension (systolic BP >179 mmHg or diastolic BP >109 mmHg)
    • History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine >200 µmol/l), cirrhosis, severe dementia, or psychosis
    • Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit)
    • Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis
    • Known atrial fibrillation or other clinically significant ECG abnormalities (at present)
    E.5 End points
    E.5.1Primary end point(s)
    Exploratory endpoints are:
    • Assessment of incidence of microembolic signals (MES) by transcranial Doppler (TCD) examination (before and after treatment)
    • Rate of MES per hour (before and after treatment)
    • Cerebral lesion analysis by DWI-NMR
    • Assessment of neurological status (NIH Stroke Scale)
    • Clinical endpoints will be summarised cumulatively i.e. before treatment, after treatment, at 3 months and at 12 months. The following endpoints will be recorded:
    o Rate of all cause death
    o Rate of stroke-related death
    o Any TIA, amaurosis fugax or stroke including haemorrhagic stroke
    • Assessment of cardiovascular outcome including myocardial infarction and re-intervention up to 3 and 12 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to 1-2 days after treatment.
    E.5.2Secondary end point(s)
    •Rate of MES per hour (before and after treatment)
    •Assessment of neurological status (NIH Stroke Scale)
    •Cerebral lesion analysis by DWI-NMR and correlation to neurological status (before and after treatment)
    •Clinical endpoints will be summarised cumulatively i.e. before treatment, 1 and 3 days after treatment, at 3 months and at 12 months. The following endpoints will be recorded:
    oRate of all cause death
    oRate of stroke-related death
    oAny TIA, amaurosis fugax or stroke including haemorrhagic stroke
    •Assessment of cardiovascular outcome including myocardial infarction and re-intervention up to 3 and 12 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to 3 months / 12 months.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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 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
    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
    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: 50
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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)
    Patients are invited for a follow up visit 3 months after receiving study treatment.
    Treatment after trial participation will be in accordance with clinical standards of the said condition.
    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 Decision2012-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-23
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