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    Summary
    EudraCT Number:2004-000904-41
    Sponsor's Protocol Code Number:XRP0673A/2002
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-08-19
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2004-000904-41
    A.3Full title of the trial
    A multinational, randomized, double-blind, double-dummy, exploratory, parallel-group, dose-ranging phase II study to evaluate the pharmacodynamics, the safety and tolerability, and the pharmacokinetics of several intravenous regimens of the factor Xa inhibitor otamixaban (XRP0673), in comparison to intravenous unfractionated heparin, in subjects undergoing non-urgent Percutaneous Coronary Intervention.
    A.3.2Name or abbreviated title of the trial where available
    The SEPIA-PCI Trial
    A.4.1Sponsor's protocol code numberXRP0673A/2002
    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 SponsorAventis Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Information not present in EudraCT
    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 nameotamixaban
    D.3.2Product code XRP0673
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNotamixaban
    D.3.9.1CAS number 219672-50-1
    D.3.9.2Current sponsor codeXRP0673
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name 5% HEPARINA
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Farmacéuticos Rovi, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameheparin sodium ( Unfractionated heparin - UFH )
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNheparin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with coronary heart disease who will be undergoing non-urgent Percutaneous Coronary Intervention (PCI)
    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
    in subjects undergoing non-urgent percutaneous coronary intervention (PCI):
    · to determine the effect of several intravenous (IV) regimens of otamixaban on the pharmacodynamic marker F1 + F2 (marker of thrombin generation) at the end of the infusion, as compared to IV unfractionated heparin (UFH)
    · and to determine the effect of several IV regimens of otamixaban on the pharmacodynamic marker anti-factor Xa (anti-FXa) activity at the end of the infusion.
    E.2.2Secondary objectives of the trial
    to identify a safe range of dosages of IV otamixaban in comparison to UFH. Safety and tolerability will include:
    · assessments of bleeding, based on the incidence of the composite endpoint of TIMI major, minor and minimal bleeding episodes up to Day 3 or hospital discharge (whichever comes first), composite endpoint of TIMI major and minor bleeds, and the components TIMI major bleeds, and TIMI minor bleeds
    · adverse events (AEs) and laboratory safety data

    to assess the effect of several IV regimens of otamixaban on clinical efficacy, as represented by the incidence of the composite endpoint of death, myocardial infarction (MI), and target vessel revascularization (urgent and non-urgent) for 30 days after randomization
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    · Men or women ≥ 18 years of age
    · Due to undergo non-urgent PCI with a femoral approach, with balloon angioplasty (with or without stent) of a single or multiple sites of native vessel(s) during the same procedure
    · Planned treatment with aspirin and clopidogrel prior to PCI (unless allergic to one of these medications).
    · Informed consent obtained in writing at enrollment into the study (oral consent alone is not allowed)
    E.4Principal exclusion criteria
    General
    · Breastfeeding or pregnancy
    · Inability to give informed consent or high likelihood of being unavailable for Day 31 follow-up
    · Treatment with other investigational agents (including placebo) or devices within 30 days days prior to enrollment or planned use of investigational drugs or devices during the study
    Cardiovascular
    · Onset of acute coronary syndrome (STEMI, unstable angina/NSTEMI) within 48 hours prior to randomization
    . Ischemic discomfort at rest within 24 hours prior to randomization
    · Congestive heart failure of New York Heart Association class III or IV at enrollment
    · Hemodynamic instability at enrollment
    · Significant valvular disease with hemodynamic impairment
    · Radial approach for the planned PCI
    Related to bleeding risk
    · Active or recent (< 3 months) significant bleeding, including gastrointestinal bleeding or gross hematuria
    · Ischemic stroke within 12 months or history of any previous hemorrhagic stroke
    · Known structural damage or other pathologic process involving the central nervous system (including, but not limited to, intracranial tumor or intracerebral vascular malformation)
    · Recent (< 1 month) trauma (including cardiac resuscitation), major surgery (including bypass surgery) or parenchymal organ biopsy
    · Uncontrolled arterial hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg)
    · Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand’s disease or hemophilia, acquired bleeding disorders, or unexplained repeated bleeding episodes)
    Related to prior/concomitant medications
    · Chronic daily use of NSAIDs or oral corticosteroids
    · Thrombolytic therapy within the previous 14 days
    · History of hypersensitivity or contraindication to unfractionated heparin
    · Treatment with unfractionated heparin, enoxaparin, nadropirin, dalteparin, reviparin, or bivalirudin within the 12 hours preceding randomization
    . Treatment with tinzaparin or fondaparinux within 24 hours preceding randomization
    · Treatment with abciximab within 10 days prior to randomization
    · Treatment with eptifibatide or tirofiban within 12 hours prior to randomization
    Laboratory values
    · Known thrombocytopenia (platelet count ≤ 100 000/μL) at enrollment
    · Known international normalized ratio (INR) > 1.2 at enrollment
    · Known estimated creatinine clearance ≤ 30 mL/min at enrollment (Cockroft and Gault formula)
    · Known clinically significant anemia (hemoglobin < 10 g/dL) at enrollment
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis variables are the following two pharmacodynamic markers:
    · F1 + F2 (marker of thrombin generation) change from baseline assessed at the end of the 3-hour infusion
    · anti-FXa activity assessed at the end of the 3-hour infusion
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 is defined as 3 months after the Day 31 telephone contact for the last subject enrolled in order to collect the last case report forms and lock the clinical database.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 930
    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 Decision2004-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-01
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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