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    Summary
    EudraCT Number:2013-001185-41
    Sponsor's Protocol Code Number:POINT
    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:2013-12-03
    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 number2013-001185-41
    A.3Full title of the trial
    Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, a randomized, double blind, multicentre clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Platelet-Oriented Inhbition in New transient ischemic attack and minor stroke
    A.3.2Name or abbreviated title of the trial where available
    Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke
    A.4.1Sponsor's protocol code numberPOINT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00991029
    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 SponsorUniversity of California San Francisco Stroke Sciences Group
    B.1.3.4CountryUnited States
    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 supportUS DHHS - National Institute of Neurological Disorders and Stroke
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynteractHCR Ltd
    B.5.2Functional name of contact pointKadifa Chambers
    B.5.3 Address:
    B.5.3.1Street AddressGemini House, Bartholomew's Walk, Cambridgeshire Business Park, Angel Drove, Ely
    B.5.3.2Town/ cityCAMBS
    B.5.3.3Post codeCB7 4EA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0) 1353 646076
    B.5.5Fax number+44 (0) 1353 661580
    B.5.6E-mailkadifa.chambers@synteractHCR.com
    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-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePlavix
    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 INNclopidogrel hydrogen sulphate
    D.3.9.3Other descriptive nameClopidogrel Bisulphate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number75 to 600
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Transient Ischemic Attack and Minor Stroke
    E.1.1.1Medical condition in easily understood language
    Mini-Stroke
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10068644
    E.1.2Term Brain stem stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10044390
    E.1.2Term Transient ischaemic attack
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether clopidogrel 75mg/day by mouth after an initial dose of 600mg, is effective in improving events related to stroke at 90 days, in patients receiving aspirin 50-325mg/day when randomized within 12 hours of time last known free of new stroke symptoms.
    E.2.2Secondary objectives of the trial
    Secondary objectives include the effect of therapy on; (1) ischemic stroke (loss of blood supply to the brain) and hemorrhagic stroke (ruptured blood vessel in the brain), (2)all-cause death (3)new handicap/disability. In addition the impact of therapy on the outcome will be evaluated in specific participant groups (e.g. African Americans and those previously taking aspirin).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    POINT Ancillary Biomarker Study (29/09/2012- 30/09/2015)
    Participants who consent to the main POINT Trial will be invited to consent to an optional ancillary study consisting of a one-time venous blood sample of approximately 10ml, collected at the time of enrollment in the trial.

    The study sample will be prepared to extract Plasma and DNA for genotyping analysis and will be used for testing whether clopidogrel resistant genotyping modify the stroke prevention response in high risk transient ischemic attack.
    E.3Principal inclusion criteria
    • Neurologic deficit (based on history or examination) attributed to focal brain ischemia and EITHER:
    o High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score >4
    Or
    o Minor ischemic stroke: residual deficit with NIHSS <3 at the time of randomization
    • Ability to randomize within 12 hours of time last known free of new ischemic symptoms.
    • Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
    • Ability to tolerate aspirin at a dose of 50-325 mg/day.
    E.4Principal exclusion criteria
    • Age <18 years.
    • TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
    • In the judgement of the treating physician, a candidate for thrombolysis, endarterectomy or endovascular intervention, unless the subject declines both endarterectomy and endovascular intervention at the time of evaluation for eligibility.
    • Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
    • Gastrointestinal bleed or major surgery within 3 months prior to index event.
    • History of nontraumatic intracranial hemorrhage.
    • Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).
    • Qualifying ischemic event induced by angiography or surgery.
    • Severe non-cardiovascular comorbidity with life expectancy <3 months.
    • Contraindication to clopidogrel or aspirin:
     Known allergy
     Severe renal (serum creatinine >2 mg/dL) or hepatic insufficiency (prior or concurrent diagnosis, with INR>1.5, or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)
     Haemostatic disorder or systemic bleeding in the past 3 months
     Current thrombocytopenia (platelet count <100 x109/l) or neutropenia/granulocytopenia (<1 x109/l)
     History of drug-induced haematologic or hepatic abnormalities
    • Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (e.g., dipyridamole, clopidogrel, ticlopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).
    • Not willing or able to discontinue prohibited concomitant medications.
    • Inability to swallow medications.
    • At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).
    • Unavailability for follow-up.
    • Signed and dated informed consent not obtained from patient.
    • Other neurological conditions that would complicate assessment of outcomes during follow-up.
    • Ongoing treatment in another study of an investigational
    therapy, or treatment in such a study within the last 7 days.
    • Previously enrolled in the POINT study.
    E.5 End points
    E.5.1Primary end point(s)
    The Primary analysis will be the intention to treat, with inclusion and treatment group defined per randomization assignment. Missing values will remain missing and subjects will be censored at their last follow up assessment (end of study or last visit prior to loss to follow-up). Kaplan-Meier estimates of the cumulative risk of an event will be reported for the maximum 90-day follow up, and the log-rank test will be used to evaluate the statistical significance of the treatment effect. The Type 1 error for the primary analysis will consider two sided alpha=0.05 significant.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.
    E.5.2Secondary end point(s)
    A number of secondary outcomes will be evaluated separately, including risk of ischemic stroke, intra-cranial haemorrhage,and the composite of the primary outcome and major haemorrhage. The influence of index event type (TIA vs. minor stroke), sex and race/ethnicity will be evaluated in subgroup analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time point for the secondary analysis will be 90 days
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Canada
    Israel
    United States
    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
    LPLV and Form 17: End of Study should be completed in the WebDCU™ system for every subject once the subject has exited the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 4150
    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)
    At the end of the study, the treating physician will discuss with the participant the best choice for antiplatelet drugs like those mentioned in the study. Depending on side effects, costs, and the participant's own preferences, clopidogrel, aspirin, or the medication aspirin/dipyridamole (also known as Aggrenox®) may be the best choice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Thames Valley Comprehensive Local Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-03-28
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