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    Summary
    EudraCT Number:2010-020219-35
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-03-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-020219-35
    A.3Full title of the trial
    Evaluating the benefit of additional platelet inhibition in acute coronary syndrome patients with high platelet reactivity undergoing PCI
    A.3.2Name or abbreviated title of the trial where available
    APACS-HPR Trial
    A.4.1Sponsor's protocol code number
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRoyal Brompton & Harefield NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 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 namePrasugrel
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 (hydrochloride)
    D.3.9.1CAS number 389574-19-0
    D.3.9.3Other descriptive nameEfient
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameClopidogrel
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNClopidogrel
    D.3.9.3Other descriptive namePlavix
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cardiovascular disease - Acute coronary syndrome
    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
    OBSERVATIONAL REGISTRY OF SCREENED PATIENTS
    To identify the proportion of patients who are good responders to routine doses of Clopidogrel and compare the events of death at 30 days.

    RANDOMISED PATIENTS
    To evaluate if reloading with Prasugrel compared to a high dose regimen of Clopidogrel results in more patients having a low platelet reactivity. Patients will be identified who have poor platelet response to previous Clopidogrel and have undergone an invasive procedure (PCI) to treat their narrowed or blocked heart vessels.

    SUBSTUDIES
    1. Title: APACS-HPR genetic substudy
    To determine the relevant influence of genetic heritage on response variability to the Clopidogrel and Prasugrel antiplatelet treatment.

    2) Title: APACS-HPR biomarker substudy
    To determine the variability of platelet inhibition to Clopidogrel or Prasugrel treatment if this is influenced by the inflammatory condition and the extent of platelet activation and blood flow to the heart muscle.
    E.2.2Secondary objectives of the trial
    (i) To compare the proportion of patients with improved platelet response between the treatment arms at hospital discharge/7 days and at 30 days.
    (ii) To compare the amount of damage to heart muscle using blood marker (CK, troponin) at 24 hours between the treatment arms
    (iii) To compare the rate of major adverse events (death, myocardial infarction, stroke, repeated revascularization) at 30 days between the treatment arms
    (iv) To compare the safety rate of major bleedings at 30 days between the treatment arms.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. APACS-HPR genetic substudy
    Objective: There is a relevant influence of genetic heritage on response variability to thienopyridine treatment. Polymorphic variants of genes encoding for platelet proteins and enzymes involved in drug metabolism have been previously linked to the platelet function phenotype and clinical outcome under clopidogrel treatment. Particular candidate genes include single nucleotide polymorphism of genes encoding for different cytochrome P450 isoenzymes (CYP 2C19*2, CYP2C19*3, CYP3A4/5), multi-drug resistance gene (ABCB1) and Paraoxonase-1 (PON1). The primary objective of the genetic substudy is to investigate the impact of candidate SNP´s involved in thienopyridine metabolism and efficacy on differences in the primary endpoint between the two randomised arms and to investigate their effects on clinical outcome in clopidogrel treated patients in the registry study.

    2. APACS-HPR biomarker substudy
    Objective: Variability of platelet inhibition under thienopyridine treatment is influenced by the inflammatory condition and the extent of platelet activation and myocardial ischemia in the course of acute coronary events. The primary objective of the biomarker substudy is to investigate the association of C-reactive protein (hsCRP) and inflammatory cytokines and chemokines (RANTES, Interleukins, TNFalpha, MCP-1, SDF-1, adiponectin) and differences in platelet reactivity between the treatment arms. Additionally, levels of biomarkers monitoring myocardial ischemia and plaque destablization (high sensitivity Troponin, soluble glycoprotein 6, Copeptin, heart-type fatty acid binding protein, myeloperoxidase) and platelet activation (soluble P-selectin, CD40 ligand) will be determined to elucidate mechanisms of differences in platelet response to antiplatelet therapy.
    E.3Principal inclusion criteria
    PATIENT INCLUSION CRITERIA REGISTRY
    a) ACS patients with intent for PCI <72 hours from admission.
    b) Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel
    c) Low platelet reactivity (HPR) PA <400 AU min by multiplate analyser (“good responders”). Blood sample to be taken at least 2 hrs after prior clopidogrel loading.
    d) Consent.

    PATIENT INCLUSION CRITERIA FOR RANDOMISED APACS STUDY
    a) ACS patients with intent for PCI <72 hours from admission.
    b) Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel
    c) High platelet reactivity (HPR) PA ≥400 AU min by multiplate analyser (“poor responders”).
    d) Initial platelet function sample at least 2 hours after pre PCI loading dose
    e) Consent.
    E.4Principal exclusion criteria
    PATIENT EXCLUSION CRITERIA RANDOMISED APACS STUDY
    a) Patients <18 years and ≥75 years
    b) Body weight <60kg
    c) Pretreatment with prasugrel within 7 days of randomisation
    d) History of stroke or transient ischaemic attack
    e) Patients with increased bleeding risk e.g.
    • recent major trauma or surgery
    • gastrointestinal bleeding or active peptic ulceration
    • Platelet count <100,000 / mm3 at the time of screening
    • Internationally Normalized Ratio (INR)> 1.5 at the time of screening
    f) Hb<10g/dL
    g) Intracranial neoplasm, arteriovenous malformation or aneurysm.
    h) Severe hepatic impairment (Child Pugh class C)
    i) Intention to use the following medications
    • oral anticoagulation
    • other antiplatelet therapy (including GPIIb/IIIa inhibitors) besides aspirin
    • nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors
    j) Female patients who are pregnant, planning pregnancy, not using reliable contraception or who are breastfeeding
    k) Known allergy, hypersensitivity or other contraindications to prasugrel or clopidgrel
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will compare the proportion of patients with improved platelet response (i.e. decreased platelet reactivity under the cut-off value of 400 Au.min) in the prasugrel re-loading arm compared to the clopidogrel re-loading arm at 4 hours after randomization in patients with initial high platelet reactivity
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    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
    The trial will end when the last patient randomised has completed 30 days of follow up.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    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 140
    F.4.2.2In the whole clinical trial 140
    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 will be assessed at the 30 day follow up visit. Their study doctor will discuss their medication and will prescibe continuing medication and make recommendations to the patient's GP.
    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 Decision2011-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-10-17
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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