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    Summary
    EudraCT Number:2008-002747-16
    Sponsor's Protocol Code Number:AR1108888
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-002747-16
    A.3Full title of the trial
    FondaparinUx Trial with UFH during Revascularization in Acute Coronary Syndromes (FUTURA)

    A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with UA/NSTEMI initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)
    A.3.2Name or abbreviated title of the trial where available
    OASIS 8 (FUTURA)
    A.4.1Sponsor's protocol code numberAR1108888
    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 SponsorGlaxoSmithKline R & D
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Arixtra 2.5 mg Injection
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous 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 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 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 Heparin Sodium Injection, ADD-Vantage Vial, 2000 USP Units per mL.
    D.2.1.1.2Name of the Marketing Authorisation holderHospira, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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 use
    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 No
    D.3.11.8Extractive medicinal product Yes
    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
    Treatment of unstable angina/non-ST elevation myocardial infarction (UA/NSTEMI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064347
    E.1.2Term Non ST segment elevation myocardial infarction
    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 the safety of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI initially treated with s.c. fondaparinux and referred for early coronary angiography.
    E.2.2Secondary objectives of the trial
    To evaluate the net clinical benefit of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI initially treated with s.c. fondaparinux and referred for early coronary angiography.

    To evaluate the relative efficacy outcomes of two dose regimens of adjunctive i.v. UFH (low or standard dose) during PCI in high risk patients with UA/NSTEMI patients initially treated with s.c. fondaparinux and referred for early coronary angiography.

    To evaluate if the bleeding and PCI-related complications associated with adjunctive UFH during PCI in UA/NSTEMI patients initially treated with s.c. fondaparinux is comparable to that observed in OASIS 5 when fondaparinux was used as the sole anticoagulant during PCI.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    NSTEACS (A Randomized Comparison of a Strategy of Culprit-Only versus Complete Revascularization with Percutaneous Coronary Intervention in Patients with Non ST elevation Acute Coronary Syndromes [NSTEACS])

    Objectives:

    To determine whether a strategy of complete revascularization with PCI is superior to a strategy of culprit vessel-only PCI in reducing the rate of death, new MI, or refractory ischemia at 1 year.

    BLOOD STUDY

    Objectives:

    To examine the association between anticoagulation intensity during fondaparinux therapy and risk of MI, stroke or death.

    To examine the association between anticoagulation intensity during fondaparinux therapy and risk of bleeding.

    To examine the association between inhibition of contact activation and risk of catheter thrombosis.
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the cohort study must meet all of the following criteria:

    Presenting or admitted to hospital with symptoms suspected to represent UA or
    NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of,
    characteristic ischemic chest pain or ischemic symptoms occurring at rest or with
    minimal activity (lasting longer than 5 minutes or requiring sublingual nitroglycerine
    for relief of the pain).

    Available to be enrolled within 48 hours of the onset of the most recent episode of
    symptoms.

    Planned coronary angiography, with PCI if indicated, within 72 hours of enrolment
    where possible.

    At least two of the three following additional criteria:
    • Age ≥ 60 years
    • Troponin T or I or CK-MB above the upper limit of normal for the local
    institution;
    • ECG changes compatible with ischemia, i.e., ST depression at least 1 mm in 2
    contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or
    transient ST elevation.

    Written informed consent dated and signed

    In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:

    Age < 21 years.

    Any contraindication to UFH or fondaparinux

    Contraindication for angiography or PCI at baseline

    Subjects requiring urgent (<120 minutes) coronary angiography as characterized by
    those with:
    • refractory or recurrent angina associated with dynamic ST-deviation
    • heart failure
    • life-threatening arrhythmias
    • haemodynamic instability

    Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin
    or UFH for treatment of the qualifying events unless the last administered (i.v. or
    s.c.) dose was:
    • ≥ 8 hours for LMWH
    • ≥60 minutes for bivalirudin
    • ≥90 minutes for UFH

    Hemorrhagic stroke within the last 12 months.

    Indication for anti-coagulation other than ACS during the index hospitalization.

    Pregnancy or women of childbearing potential who are not using an effective method
    of contraception.

    Co-morbid condition with life expectancy less than 6 months.

    Currently receiving an experimental pharmacological agent.

    Revascularization procedure already performed for the qualifying event.

    Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)

    The French subject has participated in any study using an investigational drug during the previous 56 days
    E.5 End points
    E.5.1Primary end point(s)
    The designated primary outcome is:

    • Composite of peri-PCI* major bleeding, minor bleeding or major vascular access site complications

    * Peri-PCI is defined from randomisation up to 48 hours post PCI procedure.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    UFH low dose
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA129
    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 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 trial will end when the last subject enrolled in the trial has completed their final visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 2000
    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)
    On completion of treatment within the trial, subjects will not be offered any further
    treatment with study medication. The treatment of subjects after the study has been completed will be left to the Investigator’s discretion.
    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 Decision2009-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-11
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