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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002010-19
    Sponsor's Protocol Code Number:TASC07
    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:2007-06-14
    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 number2007-002010-19
    A.3Full title of the trial
    The TASCFORCE Project:
    Tayside Screening For risk of Cardiac Events and the effect of statin on risk reduction (as evidenced by change in LV mass)
    A.3.2Name or abbreviated title of the trial where available
    TASCFORCE
    A.4.1Sponsor's protocol code numberTASC07
    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 SponsorUniversity of Dundee
    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 Zocor
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameZocor
    D.3.4Pharmaceutical form 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 Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboCapsule*
    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
    The aim of this study is to validate MRI as a screening tool for detection of early signs of heart disease. Those thought to be at the highest risk of developing cardiovascular disease will be randomised to statin/placebo intervention for 18 months to 2 years. At the end of the study they will undergo a repeat MRI and blood tests to detect any changes.
    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
    1) To screen an at-risk Tayside population for early signs of heart disease using Magnetic Resonance Imaging (MRI), as measured by left ventricular mass and gadolinium detected silent infarct.

    2) To assess the effects of statin/placebo therapy on Left Ventricular Mass (LVM) in a cohort of 800 subjects.
    E.2.2Secondary objectives of the trial
    1) To validate the MRI screening technique, which is known to be relatively non-invasive and safe, as a sensitive and specific measure of vascular risk.

    2) Assessment of Brain Natriuretic Peptide (BNP) and other vascular markers along with MRI measured LVM as marker of future Cardiovascular events (CVEs).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genetic sub-study- For research
    Healthforce- Lifestlye intervention
    E.3Principal inclusion criteria
    1. Males and Female equal to or over 40 years of age.
    2. Not requiring statin therapy by virtue of presence of CVD or CVD risk based on SIGN 97 Guideline.
    E.4Principal exclusion criteria
    1. Pregnancy, breast-feeding or women of child-bearing potential not using adequate contraception
    2. Known primary muscle disease
    3. Known atherosclerotic disease eg:
    i. previous episodes of confirmed Acute Coronary Syndrome (ACS), unstable angina; myocardial infarction with or without ST elevation; or stable CHD/CVD deemed to require statin therapy on clinical grounds, including:
    ii. Previous amputation due to severe peripheral vascular disease or severe peripheral arterial disease,
    iii. Previous central or peripheral revascularisation procedure (including coronary angioplasty, coronary artery bypass graft surgery, peripheral arterial graft surgery)
    iv. Hypertension.
    v. Heart failure.
    vi. Significant dysrhythmia or angina requiring hospitalisation in the 6 months preceding potential study entry
    vii. Previous cerebrovascular accident
    4. Other accepted indication for statin therapy according to the investigators’ current clinical practice including:
    i. Known familial hyperlipidaemia requiring drug therapy
    ii. Known diabetes (if we detect risk more than 20%, patient will be referred to his GP for proper treatment).
    iii. Those above the treatment cut off point using the Coronary Risk SIGN 97 Guidline.
    5. Known hypersensitivity or intolerance to statins.
    6. Significant biochemical abnormalities such as:
    Active liver disease or hepatic dysfunction with AST or ALT >2x upper limit of normal (ULN)
    7. Participation in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study.
    8. Other serious illness or significant abnormalities that may compromise the subject's safety or successful participation in the study.
    9. Any illness which in the doctor’s opinion means that the subject is unable to give informed consent.
    10. Known alcohol abuse.
    11. Taking any of the following medications:
    i. Use of OTC statins (other HMG-CoA reductase inhibitors).
    ii. Drugs known to be associated with rhabdomyolysis in combination with HMG-CoA reductase inhibitors (e.g. cyclosporin, erythromycin, azo anti-fungals, protease inhibitors and all macrolides)
    iii. Drugs (other than beta-blockers, diuretics, ACE inhibitors, other anti-hypertensive agents, oral hypoglycaemic agents and thyroxine replacement therapy) known to affect lipid levels, that interact with the study medications, or that may affect clinical laboratory parameters (such as isotretinoin).
    iv. Lipid-regulating drugs: probucol, fibrates and derivatives, bile acid sequestering resins. Subjects currently taking a lipid-altering drug may be considered for screening after a 4-week wash-out period except in the case of probucol where medication must have been discontinued for at least 6 months.
    12. Drinking more than two glasses of grapefruit juice per day
    E.5 End points
    E.5.1Primary end point(s)
    Primary criterion of efficacy:
    The primary criterion will be the difference in Left ventricular mass after 2 years in those receiving statins to those who did not in the Index group

    Secondary criteria efficacy:
    1. Other measures of MRI and CVEs in the Index group (gadolinium enhanced infarcts, atheroma burden)
    2. CV mortality and Events at 18m - 2 years in the Index group based on ISD Records, and General Practitioner Records, defined as the first occurrence, over the duration of follow-up of the following:
    - Myocardial Infarction (fatal and non fatal)
    - Hospitalisation for Angina
    - Requirement for endovascular procedure eg angioplasty, stent, by-pass grafting (in any vascular bed)
    - Stroke
    - Sudden Death
    - All cause mortality
    - Safety: Safety outcomes, including myositis, and other adverse events will be examined throughout the study
    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 No
    E.6.4Safety Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    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
    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 Yes
    F.3.2Patients No
    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 state5000
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 5000
    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 Decision2007-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-04-09
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