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    The EU Clinical Trials Register currently displays   31553   clinical trials with a EudraCT protocol, of which   5083   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-005260-10
    Sponsor's Protocol Code Number:123
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-17
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-005260-10
    A.3Full title of the trial
    Bivalirudin versus Heparin in NST and ST-Evaluation myocardial infarction on modern antiplatelet therapy in SWEDEHEART (the VALIDATE - SWEDEHEART-trial)

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare two treatments to patients with STEMI or NSTEMI. The study will evaluate all cause death, myocardial infarction, stroke, stent trombosis and bleeding after treated with PCI - Percutaneous coronary intervention
    A.3.2Name or abbreviated title of the trial where available
    VALIDATE-SWEDEHEART-trial
    A.4.1Sponsor's protocol code number123
    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 SponsorUppsala Clinical Research Center
    B.1.3.4CountrySweden
    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 supportDepartment of Cardiology Skåne University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSkåne University Hospital
    B.5.2Functional name of contact pointDepartment of Cardiology
    B.5.3 Address:
    B.5.3.1Street AddressGetinge vägen 4
    B.5.3.2Town/ cityLund
    B.5.3.3Post code221 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+46+4617 25 972597
    B.5.5Fax number+46+461578577857
    B.5.6E-maildavid.erlinge@med.lu.se
    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 UK Ltd Suite B, Park House 11 Milton Park Abingdon Oxfordshire OX 14 4RS GB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 IMP
    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 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) 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 LEO
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma AB Box 404, 201 24 Malmö
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 No
    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 Sodium
    D.3.9.2Current sponsor code9600
    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 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.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 STEMI and NSTEMI treated with PCI and either Bivalirudin (optional to add up to 3000U heparin in lab or up to 5000U given prehospital ) compared to Heparin 70 - 100U/kg alone
    E.1.1.1Medical condition in easily understood language
    Patients with STEMI and NSTEMI treated with PCI and either Bivalirudin (optional to add up to 3000U heparin in lab or up to 5000U given prehospital ) compared to Heparin 70 - 100U/kg alone
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10064347
    E.1.2Term Non ST segment elevation myocardial infarction
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10064345
    E.1.2Term ST segment elevation myocardial infarction
    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
    Compare all cause death, MI, stroke, stent thrombosis and bleeding event in patients with STEMI and NSTEMI treated with PCI and either Bivalirudin 1.75 mg/kg followed by an infusion of 1.75 mg/kg per hour (optional to add up to 3 000 U heparin in lab or up to 5000 U given prehospital) or heparin 70 - 100 U/kg alone

    Endpoints at 180 days (primary time point).
    - After analysis of interaction, separate analysis of the primary endpoint in the NSTEMI and STEMI groups.
    E.2.2Secondary objectives of the trial
    - Time to individual components of the primary end point see above
    - The primary end point combined with stroke
    - Primary end point in heparin subgroups based on total heparin, U/kg, max ACT.
    - TIMI flow grade after PCI.
    - Time to re-hospitalization with reinfarction as reported in SWEDEHEART.
    - Time to all-cause death or re-hospitalization with myocardial infarction (first occurring).
    - Time to target vessel revascularization as reported in SWEDEHEART.
    - Time to target lesion revascularization as reported in SWEDEHEART.
    - Time to stent thrombosis, time to restenosis, time to re-hospitalization with heart failure as reported in SWEDEHEART.
    - Heart failure and complications of PCI during index hospitalization, minor bleeding during index hospitalization as reported in SWEDEHEART
    - Length of index hospital stay as reported in SWEDEHEART.
    - Bail-out use of GpIIb/IIIa inhibitors during PCI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or
    patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
    - PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
    - Ability to provide informed consent
    - Age 18 years or older
    - Treated with bolus dose of ticagrelor or prasugrel before start of PCI

    Age 18 years or older
    E.4Principal exclusion criteria
    - Previous randomization in the VALIDATE-SWEDEHEART trial
    - Known terminal disease with life expectancy less than one year.
    - Patients with known ongoing bleeding
    - Patients with uncontrolled hypertension in the opinion of the investigator
    - Patients with known subacute bacterial endocarditis
    - Patients with known severe renal (GFR < 30 ml/min) and /or liver dysfunctions
    - Patients with known thrombocytopenia or thrombocyte function defects
    - Any other contraindication for the study medications
    - Heparin >5000U before arriving to PCI lab or >3000U given during angiography before randomization
    - GpIIb/IIIa-inhibitors have been given or are pre-planned to be given during the procedure.
    E.5 End points
    E.5.1Primary end point(s)
    Death, myocardial infarction and major bleeding event in patients at 180 days
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of primary endpoints 180 days after the event.
    E.5.2Secondary end point(s)
    Main Secondary endpoints:
    Endpoints at 180 days (primary time point).
    - After analysis of interaction, separate analysis of the primary endpoint in the NSTEMI and STEMI groups.
    - Time to individual components of the primary end point (death, myocardial infarction and major bleeding).
    - The primary end point combined with stroke as reported in the Swedish national patient registry. (These data will be available with a delay of about a year).
    - Primary end point in heparin subgroups based on total heparin, U/kg, max ACT.
    - TIMI flow grade after PCI.
    - Time to re-hospitalization with reinfarction as reported in SWEDEHEART.
    - Time to all-cause death or re-hospitalization with myocardial infarction (first occurring).
    - Time to target vessel revascularization as reported in SWEDEHEART.
    - Time to target lesion revascularization as reported in SWEDEHEART.
    - Time to stent thrombosis as reported in SWEDEHEART.
    - Time to restenosis as reported in SWEDEHEART.
    - Time to re-hospitalization with heart failure as reported in SWEDEHEART.
    - Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART.
    - Minor bleeding during index hospitalization as reported in SWEDEHEART
    - Length of index hospital stay as reported in SWEDEHEART.
    - Bail-out use of GpIIb/IIIa inhibitors during PCI.
    End points at 1 year, 2 years, 3 years, 5 years and 10 years. Annual analyses will be considered confirmatory only if all previous analyses have been significant.
    Health Economy
    - Economic evaluation based on cost-effectiveness analysis after 180 days with long-term modeling.
    - Health related quality of life (HRQOL) measured by Euro-Qol 5D (EQ-5D) using the SEPHIA registry.
    - Optional cost-effectiveness analyses at 1 year, 2 years, 3 years, 5 years and 10 years if clinical findings are revised.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 180 days, 1 year, 2 year, 3 year, 5 years and 10 years
    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 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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 3000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3000
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    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 state5900
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6000
    F.4.2.2In the whole clinical trial 6000
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SCAAR registry
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-10
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