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    Summary
    EudraCT Number:2007-005210-39
    Sponsor's Protocol Code Number:H7T-MC-TABY
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-005210-39
    A.3Full title of the trial
    A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed - The TRILOGY ACS Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
    A.3.2Name or abbreviated title of the trial where available
    Trilogy ACS
    A.4.1Sponsor's protocol code numberH7T-MC-TABY
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointDebra A. Marshall, M.D.
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis, Indiana
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1317-277-3046
    B.5.5Fax number+1317-433-1996
    B.5.6E-mailmarshall_debra_a@lilly.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 Efient 5 mg and 10 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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 namePrasugrel
    D.3.2Product code LY640315
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrasugrel
    D.3.9.1CAS number 389574-19-0
    D.3.9.2Current sponsor codeCS-747 hydrochloride salt, LY640315
    D.3.9.3Other descriptive nameLY640315
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameClopidogrel
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClopidogrel
    D.3.9.1CAS number 113665-84-2
    D.3.9.3Other descriptive nameClopidogrel bisuphate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 3
    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 Efient 5 mg and 10 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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 namePrasugrel
    D.3.2Product code LY640315
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrasugrel
    D.3.9.1CAS number 389574-19-0
    D.3.9.2Current sponsor codeCS-747 hydrochloride salt, LY640315
    D.3.9.3Other descriptive nameLY640315
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Acute Coronary Syndrome in medically managed subjects enrolled within 10 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event.
    E.1.1.1Medical condition in easily understood language
    To prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients who have a condition known as "acute coronary syndrome".
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 test the hypothesis that prasugrel and aspirin is superior to clopidogrel and aspirin in the treatment of medically managed subjects enrolled within 10 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event. Superiority will be assessed by the reduction in risk of the composite endpoint of first occurrence of cardiovascular (CV) death, myocardial infarction (MI), or stroke throughout the study.
    The primary analysis will be conducted in a hierarchical manner, with evaluation of the primary endpoint performed first in medically managed UA/NSTEMI subjects < age 75 years. Conditional on successfully establishing superiority in the primary analysis, the same composite endpoint will be evaluated in the entire population.
    E.2.2Secondary objectives of the trial
    The following secondary endpoints will be analyzed in both the population of medically managed UA/NSTEMI subjects age <75 years and the entire medically managed UA/NSTEMI population (subjects < age 75 years and subjects ≥ age 75 years).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Three substudies will be performed in Study TABY. Both cohorts (population <75 years of age and the population ≥75 years of age) will be eligible for participation in these substudies.

    1. Platelet Function Substudy (IPA substudy) part of main protocol (06February2008, H7T-MC-TABY(a)). The IPA substudy will not be run in all countries participating in the main study. Subjects who participate in the platelet function substudy will be assessed for each of the substudy objectives:
    Pharmacodynamic Objectives
    Platelet aggregation will be measured by the Accumetrics VerifyNow® P2Y12 and aspirin assays. The key platelet function objectives are:
    • To demonstrate a lower risk of the composite endpoint of CV death, MI, or stroke in subjects with greater attenuation of platelet aggregation, irrespective of baseline treatment.
    • To compare the prasugrel and clopidogrel groups with respect to degree of platelet aggregation.
    • To compare the prasugrel and clopidogrel groups with respect to intra- and inter-subject variability in platelet aggregation during maintenance dosing.
    • To assess the incidence of bleeding events by degree of platelet aggregation.

    Genomic Objectives
    • To assess the interaction between treatment groups and the presence of genetic variation in drug metabolizing enzymes and transporters on platelet function.
    • To assess the interaction between treatment group and the presence of genetic variation in drug metabolism enzymes and transporters on clinical efficacy and/or safety outcomes.

    Other Objectives
    •To assess the effect of the prasugrel and clopidogrel groups on biomarkers of inflammation (high-sensitivity C-reactive protein [hsCRP]) and hemodynamic stress (N-terminal prohormone brain natriuretic peptide [NT-proBNP] or brain natriuretic peptide [BNP]).

    2. Health Outcome Substudy Objectives. Part of main protocol (06February2008, H7T-MC-TABY(a))
    Health outcome objectives are:
    • To compare the prasugrel and clopidogrel treatment arms with respect to:
    a) Major healthcare resource use, cumulative medical costs, and incremental cost effectiveness.
    b) Health-related quality of life.
    • To examine healthcare costs and resource use as a function of both treatment assignment and degree of platelet aggregation.

    Other Objectives
    Other prespecified and exploratory analyses will be conducted, as specified in the statistical analysis plan (SAP), to include repeating the primary and all secondary analyses in the age ≥ 75 year population

    3. Protocol Sample Banking Addendum (30August2007, H7T-MC-TABY(1))
    For sites not participating in the IPA substudy

    Protocol Sample Banking Addendum(30August2007, H7T-MC-TABY(2))
    For Sites in IPA Substudy

    Sample banking is an optional part of this study. DNA banked samples will be anonymized and stored. DNA from banked samples may be used to further explore genetic relationships between disease susceptibility, disease outcomes, and drug responses.

    There is a slight difference in the collection of samples for sites which are participating in the DNA banking and performing IPA substudy.



    E.3Principal inclusion criteria
    1. Have had a UA/NSTEMI index event within 10 days (240 hours) prior to randomization (based on the disease diagnostic criteria in Section 4.1.1).
    2. Have had a medical management strategy decision made with reasonable certainty; that is, neither PCI nor CABG is planned for treatment of the index event.
    • For subjects whose medical management decision and randomization occurs no later than 72 hours following onset of the index event, prior clopidogrel treatment is not a consideration for eligibility.
    • ∙For subjects with a medical management decision who are randomized beyond 72 hours of onset of the index event, clopidogrel must be administered according to standard of care practice for ACS patients no later than 72 hours following the onset of the index event (as defined in Section 4.1.2).
    3. Have had at least 1 of the following 4 high-risk features at the time of the UA/NSTEMI event:
    • Age ≥60 years
    • Prior MI evidenced by pre-existing Q waves, or demonstration of infarction on imaging studies, or prior documentation of elevated cardiac markers.
    • Diabetes Mellitus - defined by concomitant treatment with an oral hypoglycemic agent and/or insulin.
    • Coronary revascularization at least 30 days before the onset of the index ACS event (either PCI or CABG).
    E.4Principal exclusion criteria
    Cardiovascular Exclusion Criteria
    5. Decision for medical management >72 hours after the onset of the index event without commercial clopidogrel treatment within 72 hours following the onset of the index event (Note: commercial clopidogrel treatment must continue daily thereafter until randomization).
    6. Planned PCI or CABG as treatment for the index ACS event – either during the index hospitalization or thereafter.
    7. PCI or CABG performed within the previous 30 days.
    8. STEMI as the index event.
    9. Cardiogenic shock within the previous 24 hours (defined as a systolic blood pressure <90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or hypotension requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
    10. Refractory ventricular arrhythmias within the previous 24 hours.
    11. Symptoms of New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours (see Attachment TABY.4 for NYHA CHF classifications).
    Exclusion Criteria Related to Bleeding
    12. Contraindicated for antiplatelet therapy.
    13. Received fibrinolytic therapy as initial treatment for the index event.
    14. Any history of bleeding diathesis.
    15. Clinical findings associated, in the judgment of the investigator, with an unacceptably high risk of bleeding.
    16. Any of the following:
    • History of ischemic or hemorrhagic stroke
    • Intracranial neoplasm, arteriovenous malformation, or aneurysm
    • History of any TIA symptoms.
    17. International Normalized Ratio (INR) known to be >1.5 if test is performed
    18. Platelet count of <100,000/mm3
    19. Anemia (hemoglobin [Hgb] <10 gm/dL)
    21.History of spontaneous gastrointestinal or non-gastrointestinal internal bleeding requiring in-hospital treatment, unless the event has been definitively treated and, in the investigator’s opinion, has a low likelihood of recurrence.
    22. Currently receiving hemodialysis or peritoneal dialysis.
    Prior/Concomitant Therapy Exclusion Criteria
    23. History of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).
    24. Treated with ticlopidine within 5 days of randomization.
    25. Receiving prasugrel treatment at the time of screening.
    26. Receiving oral anticoagulants at the time of screening or are anticipated to require oral anticoagulants therapy during the course of the study.
    27. Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require >2 weeks of daily treatment with NSAIDs or COX2 inhibitors during the study.
    General Exclusion Criteria
    28. Unwilling to provide or not sufficiently mentally competent to provide written informed consent.
    29. Study site personnel directly affiliated with the study or are immediate family of study site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    30. Employed by Eli Lilly and Company, Ube Industries Limited, Daiichi Sankyo Pharma Inc, the academic research organization (ARO), or the contract research organization (CRO) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical studies, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    31. Previously completed or withdrawn from this study or any other study investigating prasugrel.
    32. Received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indication at the time of study entry or are presently enrolled in another interventional drug or device study.
    33. Females who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
    34. Females of childbearing potential (that is, females who are not surgically or chemically sterilized and who are between menarche and 1 year post menopause) and do not agree to use a reliable method of birth control during the study.
    35. Concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period.
    36. Known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension).
    37.Conditions associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence.
    38. Unable to cooperate with protocol requirements and follow-up procedures.
    39. Insignificant coronary disease identified during coronary angiography performed for the index ACS event (defined as the absence of at least one stenosis in any coronary vessel visually estimated to be ≥30%).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Measure
    The primary efficacy endpoint is the time to the first occurrence of the composite of CV death, MI, or stroke defined as follows.
    1) Cardiovascular Death (CV Death):
    Death due to documented cardiovascular cause. Additionally, death not clearly attributable to noncardiovascular causes will be considered CV death.
    2) Myocardial Infarction (MI):
    The definition of MI is adapted from the universal definition of MI (Thygesen et al. 2007) and is dependent on the clinical timing of the event in relation to presenting syndrome and cardiovascular procedures. A subject who experiences any one of the following after randomization will qualify as having had an MI:
    • Elevation or re-elevation of the ST segment AND either ischemic chest pain ≥20 minutes in duration, or hemodynamic decompensation.
    • CK-MB fraction or troponin >ULN, AND either ischemic chest pain (or anginal equivalent) ≥20 minutes in duration, or ST-segment deviation ≥1 mm in one or more leads. If at the onset of the suspected event, the ischemic biomarker was still elevated as a result of the index event, then there must be demonstration of a falling biomarker level prior to the onset of the suspected event, and the subsequent peak of the ischemic biomarker must be 1.5 times the value prior to the onset of the suspected event. These criteria do not need to be met if the ischemic biomarker is not elevated prior to the onset of the suspected event.
    •CK-MB >3 times ULN on at least 1 sample within 24 hours following PCI (for subjects requiring emergent, urgent, or elective PCI at any time after randomization).
    •CK-MB >5 times ULN on at least 1 sample within 24 hours following CABG (for subjects requiring emergent, urgent, or elective CABG surgery at any time after randomization).
    •New Q waves ≥0.04 seconds or pathology distinct from that of the index event and thought to be new since randomization.
    In order to detect periprocedural MI in subjects undergoing PCI or CABG during the course of the study, it is recommended that 4 blood samples for CK-MB be drawn: 1 prior to the procedure and 3 within the first 24 hours after PCI/CABG. The second sample should be drawn at least 6 hours after PCI. The third sample should be at least 6 hours later (6 to 8 hours recommended), and the fourth sample should be drawn at least 6 hours after the third sample (6 to 8 hours recommended).
    In the rare circumstances where CK-MB testing is not available, a troponin >3 times ULN on at least 1 sample within 24 hours following PCI (for subjects requiring emergent, urgent, or elective PCI at any time after randomization) or a troponin >5 times ULN on at least 1 sample within 24 hours following CABG (for subjects requiring emergent, urgent, or elective CABG surgery at any time after randomization) may be used to define and adjudicate a periprocedural MI in place of CK-MBs levels.
    3) Stroke:
    The rapid onset of new, persistent neurologic deficit lasting more than 24 hours. In the case of clinical diagnosis of stroke, computed tomography (CT) or magnetic resonance imaging (MRI) is strongly recommended, but not required. Computed tomography or MRI scans will be considered by the CEC to support the clinical impression. Available supplemental information from head CT or MRI scans will assist in the determination if there is a demonstrable lesion compatible with an acute stroke. Furthermore, all strokes will be classified as either “ischemic” or “hemorrhagic” based on imaging data, if available, or “uncertain cause” if imaging data are not available.

    Primary endpoint events must be reported to the sponsor or designee within 24 hours after the site staff learns of the clinical event.

    All primary endpoints will be adjudicated by the CEC. Study sites should send the required documents that include the relevant completed endpoint CRFs and the requested source documentation to the CEC in a timely fashion for adjudication of the event. Additional details are available in the CEC charter.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Event driven trial
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA500
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Costa Rica
    Czech Republic
    Denmark
    Egypt
    Finland
    France
    Germany
    Greece
    Hungary
    India
    Ireland
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Malaysia
    Malta
    Mexico
    Netherlands
    New Zealand
    Panama
    Peru
    Philippines
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Tunisia
    Turkey
    Ukraine
    United States
    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 Patient Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Some patients with ACS may be too ill to sign personally. Informed consent must be signed by the study participant or authorised representative, according to local rules and regulations.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state209
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3500
    F.4.2.2In the whole clinical trial 11200
    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)
    After completion or withdrawal from the study prasugrel will not be provided. Continued treatment with clopidogrel or other therapy will be at the treating physician'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 Decision2008-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-30
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