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    Summary
    EudraCT Number:2008-005491-27
    Sponsor's Protocol Code Number:U-08-002
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-29
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-005491-27
    A.3Full title of the trial
    TAILORING OF PLATELET INHIBITION TO
    AVOID STENT THROMBOSIS

    TOPAS-1
    A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition
    A.3.2Name or abbreviated title of the trial where available
    TOPAS-1
    A.4.1Sponsor's protocol code numberU-08-002
    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 SponsorUCR Uppsala Clinical Research Center
    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 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 Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Mayers 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.3.4Pharmaceutical 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.3.11 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 No
    D.3.11.3.2Gene therapy medical product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Previous patients in the TABR study treated with Plavix 75 mg/day
    and patients with stent thrombosis within 6 months or myocardial infarction within 6 month after stenting. For the control group none of these events after stenting.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063933
    E.1.2Term Coronary stent thrombosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to establish a cut-off level of P2Y12 inhibition measured with VerifyNow that separates patients with a high and low risk of stent thrombosis during acethyl salicylic acid (ASA) and clopidogrel treatment during 6 months after stenting for coronary artery disease. The hyptothesis is to identify a level below which less than 10 % of the patients with stent thrombosis should have their results. The primary variable is the level of P2Y12 measured on Visit 2 (day 7-10) for the clopidogrel naïve patients and the single measurement for patients already on maintenance treatment with clopidogrel 75 mg o.d.
    E.2.2Secondary objectives of the trial
    1.To establish cut-off levels of P2Y12 inhibition measured within 6 months after stenting for coronary artery disease with;
    VerifyNow in patients with recurrent myocardial infarction.
    VerifyNow in patients with definite stent thrombosis and/or recurrent myocardial infarction
    VASP in patients with definite stent thrombosis.
    VASP in patients with recurrent myocardial infarction.
    VASP in patients with definite stent trombosis and/or recurrent myocardial infarction
    2.To evaluate the propotions of patients without definite stent trombosis or recurrent myocardial infarction that will be above and below the established cut-off levels mentioned above.
    3.To evaluate the relationship of the mesurements on different timepoints of P2Y12 inhibition in clopidogrel naïve patients
    4.To analyse biomarkers at the same time-point as above such as

    5.To valuate relations between genetic variation and clopidogrel reponsiveness and risk for stent thrombosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient group 1 – validation part.
    Patients fulfil inclusion criteria if they provide signed informed consent and have previously been randomised to clopidogrel treatment in the TABR study.
    Patient groups 2 and 3
    Patients must fulfil the following inclusion criteria to be included:
    1. Provide signed written informed consent.
    2. Male or female patients above 18 years old.
    3. Previous PCI and coronary stenting for coronary artery disease
    4. Previous (after coronary stenting) or current dual antiplatelet treatment (ASA 75 mg once daily (o.d) and clopidogrel 75 mg o.d). All patients need to be on treatment with ASA 75 mg once daily at least seven days prior to enrollment.
    and experienced one of the following alternatives:
    5. a) Stent thrombosis within 6 months of PCI while on dual antiplatelet treatment.
    or
    b) Experienced MI within 6 month after coronary stenting while on dual antiplatelet treatment.
    or
    c) No experience of stent thrombosis or MI for at least 6 months and until visit 1 (matched control)
    E.4Principal exclusion criteria
    General exclusion criteria:
    1. Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
    2. Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion
    3. Enrolled in either another investigational drug study or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
    4. Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel or ticlopidine).
    5. Significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator’s opinion.
    6. UCR or Accumetrics employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
    Cardiovascular Exclusion Criteria:
    7 Subjects with unstable coronary artery disease, defined as new, increased, or rest angina at screening.
    8 Subjects with significant hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure >110 mmHg) at the time of screening.
    Bleeding Risk Exclusion Criteria:
    9 Any known contraindication to treatment with an anticoagulant or antiplatelet agent.
    10. Prior history or presence of significant bleeding disorders (for example,hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding)
    11. Prior history or clinical suspicion of cerebral vascular malformations
    12. Prior history of abnormal bleeding tendency (i.e. prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure).
    13. Personal or family history of coagulation or bleeding disorders.
    14. Thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (platelet count > 500,000/mm3).
    15. History of major surgery, severe trauma, organ biopsy within 3 months prior to enrollment.
    16. Any planned surgical procedure within 20 days following inclusion.
    17. The use (or planned use) of other antiplatelet agents (besides aspirin and clopidogrel), anticoagulant or fibrinolytic agents.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the trial is to establish a cut-off level of P2Y12 inhibition measured with VerifyNow™ P2Y12 that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin (ASA) and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease.
    Less than 10 % of the patients with stent thrombosis should be found below this level.
    The primary variable is the level of P2Y12 inhibition measured as PRU with VerifyNow™ in the patients with stent thrombosis. The measurement on Visit 2 (16-26 hours after LD) for the clopidogrel naïve patients and the single measurement for patients already on clopidogrel 75mg once daily will be used for this primary endpoint.
    The primary objective of the validation part of the trial is to verify the hypothesis that the platelet inhibitory response to clopidogrel is stable over time (in patients previously enrolled in the TABR trial).
    The endpoints of the validation part of the study are the measurements with VerifyNow™ P2Y12 (PRU) and VASP (PRI, %) at differents time points. The 24 post LD, 14 and 28 days post MD measurements in the TABR-trial (historical data) and the measurements on 16-26 hours post LD in the present study will be used.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned15
    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 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
    See protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.3Elderly (>=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 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 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 state450
    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)
    It is provided in the protocol
    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 Decision2008-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-28
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