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    Summary
    EudraCT Number:2005-001481-14
    Sponsor's Protocol Code Number:TAX-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-001481-14
    A.3Full title of the trial
    LOCAL-TAX Trial: Local intracoronary administration of Paclitaxel after stent implantation for prevention of restenosis in comparison with stent implantation alone and with implantation of a Paclitaxel-eluting stent
    A.3.2Name or abbreviated title of the trial where available
    LOCAL-TAX Trial
    A.4.1Sponsor's protocol code numberTAX-001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot available
    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 Hospital Tübingen
    B.1.3.4CountryGermany
    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 TAXOL
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namenot applicable
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpaclitaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    coronary heart disease
    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
    Main objective of this clinical trial is to examine whether in patients with stable or unstable angina pectoris and / or documented myocardial ischemia in the presence of de-novo stenoses in native coronary arteries with a degree of stenosis between 50% and 99% an additional local administration of paclitaxel after implantation of a conventional stent is superior to the implantation of a conventional stent alone with respect to late lumen loss. In case of superiority it will be examined whether an additional local administration of paclitaxel after implantation of a conventional stent is not inferior to the implantation of a paclitaxel-eluting stent with respect to late lumen loss. Is this the case, superiority will be tested.
    E.2.2Secondary objectives of the trial
    1) A secondary objective of this clinical trial is the angiographical determination of the binary restenosis rate, defined as diameter stenosis of at least 50% in the stent and / or peristent area, 6 months after stent implantation.
    2) A secondary objective of this clinical trial is the angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and / or peristent area, 6 months after stent implantation.
    3) A secondary objective of this clinical trial is the angiographical determination of the minimal lumen diameter in the stent and / or peristent area, 6 months after stent implantation.
    4) A secondary objective of this clinical trial is the 6 months after stent implantation determined combined endpoint of abrupt and subabrupt closure of the target vessel, target lesion revascularisation and major adverse cardiac events including myocardial infarction and death.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: 18-80 years, gender: male and female
    - Stable or unstable angina pectoris and / or documented myocardial ischemia
    - Ability and willingness to adhere to the study conditions
    - Written informed consent
    - De-novo stenosis of coronary artery with a degree of stenosis between 50% and 99%, that is accessible to PTCA
    - Target vesses diameter of at least 2,5 mm and length of lesion below 18 mm
    E.4Principal exclusion criteria
    - Acute myocardial infarction or still elevated CK/CK-MB after acute myocardial infarction
    - Known severe arrhythmias that necessitate a long term antiarrhythmic therapy
    - Pericarditis
    - Intracardial thrombus
    - Bacterial endocarditis
    - Cardiopulmonary reanimation with cardiac massage within the last 6 months
    - Thromboembolic accident within the last 6 months
    - Severe peripheral arterial occlusive disease, that excludes the use of a 6 French catheter or that requires a special antithrombotic or anticoagulatory regime
    - Manifest hyperthyreosis
    - Neutrohile granulocytes less than 3000/mm3 and platelets below 100.000 or above 700.000/mm3
    - Renal insufficiency with serum creatinine above 1,5 mg/L
    - Severe systemic hypertension despite antihypertensive medication
    - Other diseases which might lead to protocol violations or reduce life expectancy
    - Life expectancy below 1 year
    - Poor general condition
    - Premenopausal women, women who are postmeopausal less than 2 years
    - Known allergy or hypersensitivity to one of the components of TAXOL®, to one of the stent components, to ASS, clopidogrel, heparin or contrast agent
    - Concurrent participation or participation within the last 30 days prior to screening in another drug trial or a trial with a medical device
    - Bifurcation stenosis, ostium stenosis, main stem stenosis of the target vessel
    - Severly curved or sclerosed target vessel
    - Visible thrombus in target vessel
    - Complete closure of target vessel
    - Severe impairment of left ventricular function with left ventricular ejection fraction of less than 30%
    - Patients with expected indication for operative myocardial revascularisation within the next six months
    - Patients with contraindication for aortocoronary bypass operation
    - Patients who are principally not available for a second coronary angiography 6 months after stent implantation or who have a contraindication for a second coronary angiography
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this clinical trial is the angiographical determination of the late lumen loss in the stent and / or peristent area, 6 months after stent implantation.
    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 No
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    2 different medical devices
    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 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 end of the trial is the last telephone interview of the last subject undergoing the trial which takes place at 3 years+/-60days post interventionem.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 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 state204
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 204
    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)
    In the case the experimental therapy seems to show a significant clinical advantage after termination of the study, the success of the experimental therapy could be followed up e.g. by means of a telephone interview with each study participant 1 year after stent implantation.
    Otherwise there are no diferences to normal treatment.
    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 Decision2005-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-08
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