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    Summary
    EudraCT Number:2010-023779-24
    Sponsor's Protocol Code Number:M10-1028
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-11-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-023779-24
    A.3Full title of the trial
    A Comparison of Drug Eluting and Bare Metal Stents with Bivalirudin during PCI or Bivalirudin for 4 hours in Acute Coronary Syndromes. The Eindhoven Reperfusion Study
    A.3.2Name or abbreviated title of the trial where available
    The DEBATER 2 Trial
    A.4.1Sponsor's protocol code numberM10-1028
    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 SponsorStichting Toegepast Caridologisch Onderzoek
    B.1.3.4CountryNetherlands
    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 Angiox
    D.2.1.1.2Name of the Marketing Authorisation holderThe Medicines Company
    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 nameAngiox
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 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 ACS who are scheduled for primary PCI (STEMI) or for immediate PCI < 2.5 hours or early PCI < 48 hours (NSTEMI) and who are pre-treated with HLD clopidogrel
    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
    The DEBATER 2 study is a single centre, investigator-initiated, prospective open 2x2 factorial randomized trial with independent data management, independent statistical analysis and blinded endpoint evaluation. The study is designed to determine the non-inferiority of TITANOX over EES and to determine the superiority of bivalirudin during 4 hours over bivalirudin during PCI in patients with ACS who are scheduled for primary PCI (STEMI) or for immediate PCI < 2.5 hours or early PCI < 48 hours (NSTEMI) and who are pre-treated with HLD clopidogrel, and post-treated with DD clopidogrel for 1 week after PCI.
    E.2.2Secondary objectives of the trial
    The composite of all-cause mortality, any myocardial infarction, bleeding and stroke at 30 days
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Patients who fulfill the inclusion/exclusion criteria but who are not selected or who refuse participation, will be treated according to our current routine, i.e. pre-treatment with 160 mg aspirin and HLD clopidogrel, followed by PCI with either DES or BMS, with or without GPI, with the decisions optional to the discretion of the attending intervention cardiologist. During the DEBATER 2 study a separate parallel registry will be kept of all patients referred to our centre for primary PCI and for immediate PCI or PCI <48 hrs after NSTEMI.
    - Correlation of ECG and coronary angiography
    - Fractional flow measurements
    - Subgroup analysis between the 4 allocations
    E.3Principal inclusion criteria
    STEMI < 12 hours (or STE equivalent), or NSTEMI < 48 hours
    No contraindications for PCI
    No contraindications for abciximab
    No contraindications for clopidogrel
    Informed consent from the patient

    Criteria for STEMI < 12 hours (or STE equivalent)

    Continual chest discomfort of acute onset within the last 12 hours
    ≥ 1 mm ST-segment elevation in ≥ 2 contiguous ECG leads

    STE equivalent
    ≥ 1 mm ST-segment depression in ECG leads V1-V3 (reversed ST-segment elevations of the posterior wall)
    New left bundle branch block (LBBB)
    Old LBBB or paced rhythm with:
    ST-segment elevation > 5 mm in right precordial leads V1-V3 (discordant with QRS)
    ST-segment depression/T wave inversion V1-V3
    ST-segment elevation ≥ 1 mm concordant with a large R wave

    Criteria for high-risk NSTEMI

    Patients with recurrent ischemia/chest pain
    Dynamic ECG changes (ST-segment depression or transient ST-segment elevation)
    Elevated troponin levels
    Early post infarction unstable angina
    Diabetes
    Hemodynamic instability
    Major arrhythmias (VF, VT)
    E.4Principal exclusion criteria
    Contraindication for PCI: peripheral/coronary artery disease that is inaccessible for PCI
    Contraindication for GPI: ongoing bleeding, bleeding diathesis, cerebrovascular accident in the last 6 months, major surgery/trauma in the last 6 months, platelet count < 100.000 mm3, intracranial intravenous malformation or neoplasm, malignant hypertension, INR . 1.5, severe hepatic dysfunction
    Contraindication for bivalirudin: bleeding diathesis, thrombocytopathy, thrombocytopenia, coagulopathy, recent surgery, TIA or CVA, severe uncontrolled hypertension, active peptic ulcer, severe renal insufficiency (MDRD < 30 ml/min).
    Contraindication for clopidogrel: severe hepatic dysfunction, pathological bleeding
    disorders such as peptic ulcer or intracranial bleeding
    Thrombolytic therapy within the last 24 hours
    Therapy with GPI within the last 24 hours
    Anticoagulation therapy
    C-morbid conditions with a predictable fatal outcome in the short run
    No informed consent: refusal, (sub) coma, artificial respiration, impaired mentation
    Patients who are already included in DEBATER II or in other trials
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints (for the comparison of stents):
    The device-oriented primary endpoint is the composite of cardiac death, myocardial infarction not attributable to a non-target vessel and target lesion revascularization (TLR) at 1 year.

    The patient-oriented primary endpoint is the composite of all-cause mortality, any myocardial infarction (including non-target vessel territory), any repeat revascularization (includes all target and non-target vessels).

    Primary Endpoints (for Bivalirudin):
    The device-oriented Primary Endpoint for the comparison of bivalirudin during PCI and bivalirudin during 4 hours and for the comparison of EES and TITANOX is the composite (in hierarchical order) of cardiac death, myocardial infarction not attributable to a non-target vessel and target lesion revascularization (TLR) at 30 days.

    The patient-oriented Primary Endpoint for the comparison of bivalirudin during PCI and bivalirudin during 4 hours and for the comparison of EES and TITANOX is the composite (in hierarchical order) of all-cause mortality, any myocardial infarction (including non-target vessel territory), any repeat revascularization (includes all target and non-target vessels) at 30 days.
    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 Yes
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Titanox coronary stent
    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
    - Last visit of last subject undergoing the trial

    - Premature temination if the primary endpoints have been reached at interim analysis after inclusion of half of the patients or at any other reason at the decision of the independent Data Safety Monitoring Board
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    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 state1800
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1800
    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 Decision2010-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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