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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2006-001860-22
    Sponsor's Protocol Code Number:CRT
    National Competent Authority:Iceland - IMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-21
    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 ConcernedIceland - IMCA
    A.2EudraCT number2006-001860-22
    A.3Full title of the trial
    CREATE. Cardiovascular Risk Evaluation and Attenuation of inflammation by early rosuvastatin TrEatment
    A.3.2Name or abbreviated title of the trial where available
    CREATE
    A.4.1Sponsor's protocol code numberCRT
    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 SponsorKarl Andersen
    B.1.3.4CountryIceland
    B.3.1 and B.3.2Status of the sponsor
    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 Crestor
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    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 namerosuvastatin
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameROSUVASTATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Patients with chest pain at rest or minimal physical activity of at least 20 minutes duration will be considered for inclusion in this study. To be eligible, patients have to be considered of low risk after being stable during a minimum period of 6 hours in the chest pain unit.
    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
    To evaluate whether 6 months treatment with rosuvastatin (Crestor) 20 mg o.d. compared to no rosuvastatin treatment will lead to:
    -significant reduction in serum myeloperoxidase (MPO) and hs-CRP levels at 3 and 12 months after randomiszation
    in low risk patients after discharge from a Univeristy Hospital chest pain unit.
    E.2.2Secondary objectives of the trial
    To evaluate whether 6 months treatment with rosuvastatin (Crestor) 20 mg o.d. compared to no rosuvastatin treatment will lead to significant reduction in
    -serum serum amyloid A (SAA)
    -serum ICAM-1
    -serum MCP-1
    -serum IL-8 and IL-6
    -serum CD40L
    in low risk patients after discharge from a Univeristy Hospital chest pain unit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with chest pain at rest or minimal physical activity of at least 20 minutes duration will be considered for inclusion in this study. To be eligible, patients have to be considered of low risk after being stable during a minimum period of 6 hours in the chest pain unit. They have to have at least two negative measurments of troponin T (less than 0.1 mg/ml) drawn from periferal blood at 6 hour intervals. They may or may not have ischemic changes on EKG´s. After observation in the chest pain unit the patients that are considered not to have myocardial infarction or other need for hospital admission will be invited to participate in the study. These patients will be referred for a symptom limited exercise stress tesing on bicycle ergometry at a follow-up visit 1-2 weeks after their initial evaluation. The patients who have elevated hs-CRP levels at the initial visit indicating an increased cardiovascular risk will be randomized to open-label treatment with rosuvastatin 20 mg o.d. or no statin treatment. Patients with a previous history of ischemic heart disease, statin therapy, chronic or acute disease which can involve increased inflammatory activity will be excluded from the study. Blood samples will be collected for measurement of several markers of inflammation at baseline and 3 and 12 months after randomization. At 3 and 12 months clinical re-evalutation will be made at a follow-up visit, new blood samples collected for measurement of inflammatory markers and major adverse clinical events will be recorded.

    To be randomized, patients have to fulfill all of the following criteria:
    i. Patients considered at low risk of developing myocardial infarction after observation in the chest pain unit by at least two negative measurements of troponin T
    ii. No sign of ongoing ischemia at rest
    iii. Elevated hs-CRP
    iv. Informed consent
    E.4Principal exclusion criteria
    i. Elevated troponin T within the previous 30 days
    ii. Previous history of atherosclerotic disease
    iii. Need for hospitalisation due to myocardial instability or infarction
    iv. Inability to perform excercise stress test
    v. Bundle branch block or pacemaker rhythm precluding evalutation of ischemia
    vi. Any condition, acute or chronic that is known to increase levels of inflammatory markers, (i.e. infection, arthritis, iflammatory bowel disease etc.)
    vii. Ongoing statin treatment
    viii. Patients who after examination turn out to have any other explanation for their chest pain than cardiac disorders
    E.5 End points
    E.5.1Primary end point(s)
    i. Primary EP: Suppression of inflammatory markers, hs-CRP and MPO
    ii. Secondary EP: Major adverse clinical events (MACE: death, myocardial infarction or need for revascularization) at 12 months.
    iii. Tertiary EP: Suppression of an extensive panel of markers as described above.
    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 Yes
    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 Information not present in EudraCT
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 Information not present in EudraCT
    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 end of the trial will be the date when the last patient has completed the last visit on stuyd medication (one year after randomization). This is estimated to be 2 years from study start.
    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 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) 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 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 state100
    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 Decision2007-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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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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