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    Summary
    EudraCT Number:2011-001686-40
    Sponsor's Protocol Code Number:A01811
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-06-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-001686-40
    A.3Full title of the trial
    INTRACORONARY STENTING AND ANTITHROMBOTIC REGIMEN: ADJUSTING ANTIPLATELET TREATMENT IN PATIENTS BASED ON PLATELET FUNCTION TESTING - ISAR ADAPT-PF
    PROSPEKTIVE, RANDOMISIERTE STUDIE ZUR ANTITHROMBOZYTÄREN WIRKUNG VON TICAGRELOR VERSUS PRASUGREL BEI PATIENTEN MIT INSUFFIZIENTEM ANSPRECHEN AUF CLOPIDOGREL NACH KORONARINTERVENTION - ISAR ADAPT-PF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ticagrelor vs. Prasugrel in patients with Clopidogrel low response - ISAR ADAPT-PF
    Ticagrelor vs. Prasugrel bei Patienten mit unzureichendem Ansprechen auf Clopidogrel - ISAR ADAPT-PF
    A.3.2Name or abbreviated title of the trial where available
    ISAR ADAPT-PF
    A.4.1Sponsor's protocol code numberA01811
    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 SponsorGerman Heart Centre Munich, Department of Cardiovascular Diseases
    B.1.3.4CountryGermany
    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 supportGerman Heart Centre Munich, Department of Cardiovascular Diseases
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISAResearch Center
    B.5.2Functional name of contact pointISAResearch Center
    B.5.3 Address:
    B.5.3.1Street AddressLazarettstr. 36
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80636
    B.5.3.4CountryGermany
    B.5.4Telephone number+498912181534
    B.5.5Fax number+498912181539
    B.5.6E-mailmerzljak@dhm.mhn.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Efient
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly 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.3.1Product nameEfient
    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.3.8INN - Proposed INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.4EV Substance CodeSUB30236
    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.IMP: 2
    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 AB
    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.3.1Product nameBrilique
    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.3.9.1CAS number 274693-27-5
    D.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    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
    Effect of Ticagrelor and Prasugrel in patients with insufficient responding to Clopidogrel after coronary intervention (non-inferiority of Ticagrelor vs. Prasugrel)
    Wirkung von Ticagrelor und Prasugrel bei Patienten mit insuffizientem Ansprechen auf Clopidogrel nach Koronarintervention (Nicht-Unterlegenheit von Ticagrelor gegenüber Prasugrel)
    E.1.1.1Medical condition in easily understood language
    Ticagrelor vs. Prasugrel in patients with Clopidogrel low response
    Ticagrelor vs. Prasugrel bei Patienten mit unzureichendem Ansprechen auf Clopidogrel
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10003601
    E.1.2Term Atherosclerosis
    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
    Ticagrelor is not inferior to Prasugrel with regard to the inhibition of platelet aggregation in patients with insufficient response to Clopidogrel.
    Ticagrelor ist Prasugrel in Bezug auf Thrombozytenaggregations-hemmung bei Patienten mit insuffizientem Ansprechen auf Clopidogrel nicht unterlegen.
    E.2.2Secondary objectives of the trial
    The objective of this clinical trial is to measure the degree of the inhibition of platelet aggregation by the two active substances Ticagrelor and Prasugrel in patients, who received a coronary stent implantation and show an insufficient responding to Clopidogrel after this intervention.
    The measurement is done by means of full-blood impedance aggregometry using Multiplate Analyzer.
    Ziel dieser klinischen Studie ist es, bei Patienten nach koronarer Stentimplantation und mit insuffizientem Ansprechen auf Clopidogrel das Ausmaß der Hemmung der Thrombozytenaggregation durch Ticagrelor und Prasugrel in diesem Patientenkollektiv mittels Vollblut-Impedanz-Aggregometrie im Multiplate Analyzer zu messen.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Investigation of the genetic status with regard to the existence of the CYP2C19*2 allele
    Untersuchung des genetischen Status in Bezug auf das Vorhandensein des CYP2C19*2 Allels
    E.3Principal inclusion criteria
    - patients after coronary intervention
    - insufficient inhibition of platelet aggregation after Clopidogrel loading
    - informed, written consent
    - Patienten nach Koronarintervention
    - Unzureichende Thrombozytenaggregationshemmung nach Clopidogrel loading
    - schriftliche Einverständniserklärung
    E.4Principal exclusion criteria
    - age < 18 years >, > 80 years
    - body weight < 60 kg
    - surgical intervention < 6 weeks
    - apoplexy in anamnesis
    - cardiogenic shock
    - oral anticoagulation
    - GPIIb/IIIa antagonists < 10 days or periprocedural
    - platelet count < 100.000/µl
    - increased risk for bradycardia
    - severe liver dysfunction
    - dialysis-dependent renal insufficiency
    - simultaneous taking of CYP3A4 inhibitors
    - Alter <18 Jahre, > 80 Jahre
    - Körpergewicht < 60 kg
    - Operativer Eingriff vor < 6 Wochen
    - Apoplex in der Anamnese
    - Kardiogener Schock
    - Orale Antikoagulation
    - GPIIb/IIIa Antagonisten < 10 Tage oder periprozedural
    - Thrombozytenzahl < 100.000/µl
    - Erhöhtes Risiko für Bradykardien
    - schwere Leberfunktionsstörung
    - dialysepflichtige Niereninsuffizienz
    - gleichzeitige Einnahme von CYP3A4 Inhibitoren
    E.5 End points
    E.5.1Primary end point(s)
    ADP-induced platelet aggregation on 2nd. day after randomization
    ADP-induzierte Thrombozytenaggregation am Tag 2 nach Randomisierung
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 2 after randomization
    Tag 2 nach Randomisierung
    E.5.2Secondary end point(s)
    - (1)portion of patients with insufficient inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off > 468 AU*min) on the 2nd. day after randomization
    - (2)portion of patients with exceeding inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off < 188 AU*min) on the 2nd. day after randomization
    - (3)ADP-induced platelet aggregation, point in time: 2 weeks after randomization during Ticagrelor or Prasugrel maintenance therapy
    - (1)Anteil der Patienten mit insuffizienter Hemmung der Thrombozytenaggregation in der Ticagrelor oder in der Prasugrel Gruppe (cut-off > 468 AU*min) am Tag 2 nach Randomisierung
    - (2)Anteil der Patienten mit übermäßiger Thrombozytenaggregations-hemmung in der Ticagrelor oder in der Prasugrel Gruppe (cut-off < 188 AU*min) am Tag 2 nach Randomisierung
    - (3)ADP-induzierte Thrombozytenaggregation 2 Wochen nach Randomisierung unter Ticagrelor oder Prasugrel Erhaltungstherapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    - concerning points (1) and (2): day 2 after randomization
    - concerning point (3): 2 weeks after randomization
    - für die Punkte (1) und (2): Tag 2 nach Randomisierung
    - für den Punkt (3): 2 Wochen nach Randomisierung
    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 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 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 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) Yes
    E.8.2.2Placebo No
    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 concerned2
    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 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
    Germany
    Hungary
    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
    letztes Follow-up des zuletzt in die Studie aufgenommenen Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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 take Ticagrelor or Prasugrel (as during the trial) for altogether 6 months - following the advice of the treating physician
    Patienten nehmen Ticagrelor oder Prasugrel (wie während der Studie) für insgesamt 6 Monate - entsprechend der Beratung durch den behandelnden Arzt
    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 Decision2011-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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