Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-002314-39
    Sponsor's Protocol Code Number:MDCO-BIV-12-02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002314-39
    A.3Full title of the trial
    Bivalirudin Infusion for Ventricular Infarction Limitation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bivalirudin Infusion for Ventricular Infarction Limitation
    A.3.2Name or abbreviated title of the trial where available
    BIVAL
    A.4.1Sponsor's protocol code numberMDCO-BIV-12-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe Medicines Company
    B.1.3.4CountrySwitzerland
    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 supportThe Medicines Company UK Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Medicines Company
    B.5.2Functional name of contact pointGlobal Health Science Center
    B.5.3 Address:
    B.5.3.1Street Address8 Sylvan Way
    B.5.3.2Town/ cityParsippany
    B.5.3.3Post codeNJ 07054
    B.5.3.4CountryUnited States
    B.5.4Telephone number00800 843 63326
    B.5.5Fax number001973-656-1929
    B.5.6E-mailmedical.information@themedco.com
    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 250 mg powder for concentrate for solution for injection or infusion
    D.2.1.1.2Name of the Marketing Authorisation holderThe Medicines Company UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIVALIRUDIN
    D.3.9.1CAS number 128270-60-0
    D.3.9.4EV Substance CodeSUB05862MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.2.1.1.1Trade name Heparin sodium 5,000 I.U./ml solution for injection or concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderWockhardt UK Ltd
    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 nameHeparin sodium 5,000 I.U./ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHeparin Sodium
    D.3.9.1CAS number 01/08/9041
    D.3.9.3Other descriptive nameHEPARIN SODIUM
    D.3.9.4EV Substance CodeSUB02478MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 presenting with a primary Percutaneous Coronary Intervention for a large acute myocardial infarction -ST elevation myocardial infarction (STEMI).
    E.1.1.1Medical condition in easily understood language
    Patients undergoing primary Percutaneous Coronary Intervention for a large acute myocardial infarction.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10000929
    E.1.2Term Acute myocardial infarction, unspecified site, episode of care unspecified
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine whether treatment with bivalirudin, compared with treatment with Unfractionated Heparin (UFH), for primary Percutaneous Coronary Intervention (PPCI) in large ST- segment elevation myocardial infarction (STEMI) can reduce infarct size assessed by cardiac magnetic resonance (CMR) at 5 days (defined as 5 days +/- 36 h from randomisation) after PPCI
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine the effects of bivalirudin compared with UFH treatment for PPCI in STEMI on:
    • Other CMR derived parameters of myocardial recovery 5 days after PPCI (i.e. left ventricular ejection fraction [LVEF], myocardial salvage index [MSI] and micro-vascular obstruction [MVO]).
    • LVEF as assessed by CMR at 90 days
    • Markers of thrombin activity and cell injury after reperfusion
    • Coronary flow and microcirculation at end of PCI
    • Survival at 90 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
    Title: Index microcirculatory resistance (IMR) and collateral flow index (CFI) sub-study
    Objective: This sub-study hypothesizes that infusion of bivalirudin compared with UFH during primary PCI will reduce myocardial microvascular damage measured by the Index of Microcirculatory Resistance (IMR).
    E.3Principal inclusion criteria
    Patients may be included in the study if they meet all of the following criteria:
    1.≥ 18 years
    2.Experience ischemic symptoms of >20 min and <12 h and have a diagnosis of STEMI with ST segment elevation of ≥1 mm in ≥2 contiguous precordial leads, or presumably new left bundle branch block
    3. Provide written informed consent, or witnessed consent in countries and sites where such patient consenting is applicable, before initiation of any study related procedures
    4. Have TIMI 0 or 1 flow in the IRA on initial angiogram
    5. Fulfill angiographic criteria/score for a large infarction based on initial angiogram (APPROACH score of >/=21)
    6. Are candidates for PPCI
    7. Administration of an initial dose of 150-325 mg orally (or 250-500 mg IV) and a loading dose of any approved P2Y12 inhibitor
    E.4Principal exclusion criteria
    Patients will be excluded from the study if any of the following exclusion criteria apply prior to enrollment:
    1. Contraindication or known hypersensitivity to bivalirudin or UFH
    2. Refusal to receive blood transfusion/products
    3. Subjects requiring staged coronary artery bypass graft (CABG) procedure within the first 90 days
    4. Known international normalized ratio (INR) ≥ 2 or known prothrombin time (PT) >1.5 times upper limit of normal on the day of the index PPCI, or known history of bleeding diathesis
    5. Therapy with vitamin K antagonists (VKA), within 72 h of PPCI
    6. Therapy with dabigatran, rivaroxaban or other oral anti-Xa or antithrombin agents within 48 h of PPCI
    7. History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass, aneurysm, arteriovenous malformation, or recent head injury (within the last 5 days)
    8. Subjects with previous history of Q-wave MI
    9. Known glomerular filtration rate (GFR) <30 milliliter (mL)/minute (min) or dialysis dependent
    10. Major surgery within the previous 30 days
    11. Minor surgery/biopsy exclusions in the past 3 days
    12. Upper gastrointestinal or genitourinary bleed 30 days prior to randomisation
    13. Stroke or transient ischemic attack 30 days prior to randomisation
    14. Administration of thrombolytics or GPI 72 h prior to PPCI
    15. Administration of enoxaparin 8 h prior to PPCI
    16. Administration of bivalirudin 12 h prior to PPCI
    17. Administration of fondaparinux or other LMWH 24 h prior to PPCI
    18. Known contraindications to aspirin or P2Y12 inhibitors
    19. Known allergy that cannot be pre-medicated to iodinated contrast
    20. Known contraindication to CMR
    21. Women of child bearing potential (1)
    22. Previous enrolment in this study
    23. Treatment with other investigational drugs or devices within the 30 days preceding enrolment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached
    24. Patients with a body weight > 150 kg

    (1) Child bearing potential is defined as:
    A female patient is considered to have childbearing potential unless she meets at least one of the following criteria:
    • Age ≥50 years and naturally amenorrhoeic for ≥ 1 year*
    • Premature ovarian failure confirmed by a specialist gynaecologist
    • Previous bilateral salpingo-oophorectomy, or hysterectomy.
    • XY genotype, Turner’s syndrome, uterine agenesis.
    *Amenorrhoea following cancer therapy does not rule out childbearing potential
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the trial is infarct size assessed by contrast enhanced cardiac magnetic resonance imaging (CMR) at 5 days post-PPCI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    primary endpoint: 5 days post-PPCI
    E.5.2Secondary end point(s)
    The secondary endpoints of this trial are:
    • CMR micro-vascular obstruction (MVO) assessment at 5 days
    • CMR myocardial salvage index (MSI) at 5 days
    • CMR assessment of LVEF at 5 days
    • CMR assessment of LVEF at 90 days
    • TIMI flow and Myocardial Blush Grade (MBG) at end of PPCI
    • In-hospital net adverse clinical events (NACE) at 5 days or discharge, whichever comes first (death, re-infarction, ischaemia driven revascularisation [IDR], and Bleeding Academic Research Consortium [BARC] ≥3 bleeding)
    • Death at 90 days
    E.5.2.1Timepoint(s) of evaluation of this end point
    • CMR micro-vascular obstruction (MVO) assessment - 5 days
    • CMR myocardial salvage index (MSI) - 5 days
    • CMR assessment of LVEF - 5 days
    • CMR assessment of LVEF - 90 days
    • TIMI flow and Myocardial Blush Grade (MBG) - end of PPCI
    • In-hospital net adverse clinical events (NACE) - 5 days or discharge, whichever comes first (death, re-infarction, ischaemia driven revascularisation [IDR], and Bleeding Academic Research Consortium [BARC] ≥3 bleeding)
    • Death - 90 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) Yes
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months9
    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 months9
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    as per the protocol and standard of care for that condition.
    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 Decision2014-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 07 21:37:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA