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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-002291-41
    Sponsor's Protocol Code Number:1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-002291-41
    A.3Full title of the trial
    The effect of administering VITamin K preprocedural on the vitamin K dependent coagulation factors and the INR in patients anticoagulated with ACEnocoumarol
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of administering VITamin K preprocedural on the vitamin K dependent coagulation factors and the INR in patients anticoagulated with ACEnocoumarol
    A.3.2Name or abbreviated title of the trial where available
    VITKACE
    A.4.1Sponsor's protocol code number1
    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 SponsorGelderse Vallei 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 supportTrombosedienst Neder-Veluwe
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGelderse Vallei Hospital
    B.5.2Functional name of contact pointdr. R. Bemelmans
    B.5.3 Address:
    B.5.3.1Street AddressWilly Brandtlaan 10
    B.5.3.2Town/ cityEde
    B.5.3.3Post code6716 RP
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310318434343
    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 Vitamin K
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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
    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 INNFytomenadion
    D.3.9.3Other descriptive nameVITAMIN K
    D.3.9.4EV Substance CodeSUB16472MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Adult patients using acenocoumarol and planned to undergo an invasive procedure for which the effect of the anticoagulants should be reversed.
    E.1.1.1Medical condition in easily understood language
    Adult patients treated with anticoagulatrion that are planned to undergo an invasive procedure for which the effect of the anticoagulants should be reversed.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    To identify which coagulation factors are involved in inadequate INR normalization after vitamin K administration 36-48 hours prior to invasive procedures in patients that continue acenocoumarol perioperatively.
    E.2.2Secondary objectives of the trial
    - To assess the proportion of patients reaching target INR <1.8 at the day of the invasive procedure after the local procedure at ZGV.
    - To assess the number of patients experiencing either thromboembolic or bleeding complications after the administration of 10 mg vitamin K.
    - To assess the time between the invasive procedure and recovery of the INR to a therapeutic level after the local procedure.
    - To store a whole blood sample from each patient for pharmacogenetics analyses, which can be used to correlate the change in coagulation factors to.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients on acenocoumarol requiring an invasive procedure.
    E.4Principal exclusion criteria
    - Age < 18 years.
    - Patients requiring periprocedural bridging therapy according to our local protocol based on national guidelines with low-molecular-weight-heparin (LMWH).
    - Inherited or acquired coagulopathies.
    - Inability or incompetency to give informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Prothrombin and factor VII activity at the day of the invasive procedure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure.
    E.5.2Secondary end point(s)
    - The number of patients with an INR <1.8 just prior to the invasive procedure.

    - Number of thromboembolic or bleeding events occurring within 30 days after the intervention.
    According to the International Society of Thrombosis and Haemostatis (ISTH) guidelines bleeding complications are defined as major if they are fatal, symptomatic bleeding intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and / or lead to fall In hemoglobin of 1.24 mmol/L or more, or leading to a blood transfusion of two or more units of whole blood or red cells.9 Also, thromboembolic events (such as deep venous thrombosis, TIA/stroke, peripheral embolism) are recorded.

    - Time to achieve therapeutic INR in acenocoumarol users who are administered a single dose of vitamin K 36-48 hours before the invasive procedure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state80
    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)
    not applicable
    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 Decision2018-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-29
    P. End of Trial
    P.End of Trial StatusOngoing
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