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    Summary
    EudraCT Number:2012-005803-42
    Sponsor's Protocol Code Number:2012-12
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-01-31
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-005803-42
    A.3Full title of the trial
    Evaluation of platelet function following cessation of ticagrelor - a study in patients with acute coronary syndrome and PCI with coronary stent
    Utvärdering av trombocytfunktionen efter utsättande av ticagrelor -en studie på patienter med akut coronart syndrom och PCI med coronart stent
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of platelet function following cessation of ticagrelor - a study in patients with acute coronary syndrome and PCI with coronary stent
    Utvärdering av trombocytfunktionen efter utsättande av ticagrelor -en studie på patienter med akut coronart syndrom och PCI med coronart stent
    A.4.1Sponsor's protocol code number2012-12
    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 SponsorUniversitetssjukhuset Örebro
    B.1.3.4CountrySweden
    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 supportUniversitetssjukhuset Örebro, ANIVA klinken
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitetssjukhuset Örebro, USÖ
    B.5.2Functional name of contact pointANIVA-kliniken, USÖ
    B.5.3 Address:
    B.5.3.1Street AddressUniversitetssjukhuset Örebro
    B.5.3.2Town/ cityÖrebro
    B.5.3.3Post code701 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+4619 602 10 00
    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 Brilique
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Tablet
    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.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    Return of platelet function following cessation of oral anti-platelet treatment with ticagrelor
    Trombocytfunktionens återkomst efter det att blodförtunnande medicinering med ticagrelor upphört
    E.1.1.1Medical condition in easily understood language
    Return of platelet function following cessation of oral anti-platelet treatment with ticagrelor.
    Trombocytfunktionens återkomst efter det att blodförtunnande medicinering med ticagrelor upphört.
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    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
    How does cessation of ticagrelor treatment influence the ability of platelet aggregation?
    Hur påverkas trombocyternas förmåga att aggregera i samband med avslutad ticagrelor behandling?
    E.2.2Secondary objectives of the trial
    Can cessation of ticagrelor treatment influence total blood coagulability and could this determine the time to start of safe surgery?
    Which method used to determine residuel effects of ticagrelor on platelet aggregation is most sensitive?
    Kan avslutad ticagrelor behandling avspeglas i den totala koagulationsförmågan och kan detta vara avgörande för när kirurgin kan äga rum efter avslutad ticagrelor behandling?
    Vilka av de metoder som idag används för mätning av ticagrelor effekt är mest känslig för detektion av kvarvarande effekt av ticagrelor behandling?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 12 months (+/- one week) treatment with double platelet blockade in the form of ASA and ticagrelor following PCI
    2. Age ≥ 45 years
    3. Signed and dated Informed Consent
    4. The subject is willing and judged capable of following the protocol throughout the study
    1. 12 månaders (+/- en vecka) behandling med dubbel trombocytblockad i form av ASA och ticagrelor efter PCI.
    2. Ålder ≥ 45 år
    3. Signerat och daterat informerat samtycke. 4. Försökspersonen vill och bedöms kunna följa protokollet under studietiden.
    E.4Principal exclusion criteria
    1. Resistance against ticagrelor treatment (so-called “non-responders”)
    2. Other oral anti-platelets agents other than ticagrelor 180 mg and ASA 75 mg/day
    3. Concurrent treatment with fluvoxamine, fluoxetine, moklobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxkarbazepine or chloramphenicol.
    4. Oversensitivity/allergy to ticagrelor
    5. Pregnancy or breastfeeding
    1. Resistens mot ticagrelor behandling (s.k. "non-responder")
    2. Annan blodförtunnande behandlingsregim än ticagrelor 180 mg + ASA 75 mg/dag
    3. Samtidig behandling med fluvoxamin, fluoxetin, moklobemid, vorikonazol, flukonazol, ticlopidin, ciprofloxacin, cimetidin, karbamazepin, oxkarbazepin eller kloramfenikol
    4. Överkänslighet/allergi mot ticagrelor
    5. Graviditet eller amning
    E.5 End points
    E.5.1Primary end point(s)
    Number of days following cessation of ticagrelor treatment that the platelet function is back to normal (< 20 % residual effect ) measured with platelet inhibition test (Verify Now Aggregometry).
    Antal dagar efter avslutat ticagrelor behandling trombocyt funktionen återgår till normal (< 20 % påverkan) mätt med trombocythämnings test (VerifyNow aggregometri)</
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood sampling before the last treatment (- day 3 to day 0 = last day of treatment) and day 1, 3, 5, 8 and 10.
    Blodprovstagning innan sista behandling (-dag 3 till dag 0 =sista behandlingsdagen) samt dag 1, 3, 5, 8 och 10.
    E.5.2Secondary end point(s)
    1. Influence on whole blood coagulation measured with thrombelastography when the platelet inhibition is > 45 units. 2. Which method is the most sensitive for measuring platelet inhibition following cessation of ticagrelor treatment: Multiplate” or VerifyNow?
    1. Påverkan på helblodskoagulation mätt med tromboelastografi då trombocythämning är > 45 units. 2. Vilken metod är mest känslig för att mäta trombocythämning efter avslutad ticagrelor behandling: Multiplate” eller VerifyNow
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood sampling before the last treatment (day - 3 to day 0 = last day of treatment) and day 1, 3, 5, 8 and 10.</
    Blodprovstagning innan sista behandling (-dag 3 till dag 0 =sista behandlingsdagen) samt dag 1, 3, 5, 8 och 10.
    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 No
    E.6.5Efficacy No
    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) 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 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 No
    E.8.2.4Number of treatment arms in the trial1
    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
    LVLS - sista patienten genomgår sista blodprovstagningen
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.1.1In 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: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state25
    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 included in the study following cessation of ticagrelor treatment. Blood-sampling is initiated within 3 days before the cessation and the last blood sample is taken 8 and 10 days after the treatment cessation. No additional patient follow-up is performed.
    Patienterna inkluderas i studien i samband med avslutad ticagrelor behandling. Blodprovstagning påbörjas inom 3 dagar innan avslut och sista blodprov tas 8 och 10 dagar efter avslutad behandling. Ingen ytterligare uppföljning av patienten.
    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 Decision2013-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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