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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2008-005140-16
    Sponsor's Protocol Code Number:KAI-9803-004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-005140-16
    A.3Full title of the trial
    Inhibition of delta-PROTEin kinase C for the reducTION of infarct size in Acute Myocardial Infarction (PROTECTION AMI)
    A.3.2Name or abbreviated title of the trial where available
    PROTECTION AMI
    A.4.1Sponsor's protocol code numberKAI-9803-004
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number65,818
    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 SponsorKAI PHARMACEUTICALS INC
    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 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 No
    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.3.2Product code KAI-9803
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 949100-39-4
    D.3.9.2Current sponsor codeKAI-9803
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number133
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for infusion*
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myocardial Infarction
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10028595
    E.1.2Term Myocardial infarct
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effect of KAI-9803 compared with placebo on infarct size following anterior STEMI as assessed by CK-MB AUC during the index hospitalization in subjects undergoing primary PCI.
    E.2.2Secondary objectives of the trial
    The following secondary objectives will be independently assessed in the anterior and inferior STEMI cohorts: Assess the effect of KAI-9803 compared with placebo on ST recovery area-under-the-curve as measured by continuous 12-lead ECG monitoring Assess the effect of KAI-9803 compared with placebo on recurrent ischemia as measured by continuous 12-lead ECG monitoring Assess the effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias Assess the effect of KAI-9803 on other markers of infarct size including: total and estimated peak CK, total and estimated peak troponin I and estimated peak CK-MB undergoing primary PCI during the index hospitalization To assess the effect of KAI-9803 compared with placebo on serum NT-pro-B-type natriuretic peptide levels Assess the effect of KAI-9803 compared with placebo on the incidence of contrast-induced nephropathy Assess the safety and tolerability KAI-9803
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. b. Subject is at least 18 years old. c. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test confirmed before randomization. WOCBP must be willing to use an acceptable method of contraception to avoid pregnancy for 10 days after randomization. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea &amp;#8805;12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential. d. Subject presents with acute STEMI and has a planned emergent primary PCI procedure. e. Subject must have a minimum of 30 minutes of continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset. f. Subject must have persistent ST elevation of: &amp;#8805; 2 mm in at least two contiguous precordial leads indicative of anterior MI location (leads V1-V4; anterior STEMI cohort) or persistent ST elevation of &amp;#8805; 2 mm in two inferior leads (leads II, III or aVF) coupled with ST depression in two contiguous anterior leads for a total of at least 8 mm (inferior STEMI cohort).
    E.4Principal exclusion criteria
    a.Intraventricular conduction defect (including left bundle branch block), or paced rhythm that would obscure the diagnosis of acute STEMI. b. Persistent systolic blood pressure <90 mm Hg (i.e., unresponsive to IV fluids). c. Currently receiving vasopressors (e.g., norepinephrine) or inotropes (e.g., dobutamine). d. History of end stage renal disease requiring hemodialysis or peritoneal dialysis. e. Known history of severe hepatic dysfunction (e.g., cirrhosis, ascites) or clinically jaundiced at randomization. f. Any prior coronary artery bypass grafting (CABG). g. Treatment with intravenous fibrinolytic therapy (e.g., alteplase, reteplase, tenecteplase, and streptokinase) within the 72 hours prior to presentation. h. Women who are pregnant or breast-feeding. i. Inability to comply with study procedures, including inability to undergo cardiac catheterization or primary PCI. j. Serious concurrent medical condition (e.g. malignancy) likely to result in death during next 12 months. k. Participation in a study of experimental therapy (drug or device) within 30 days of presentation. l. Clinical suspicion of non-thrombotic (e.g., pericarditis, vasospasm, illicit drug use) cause for ST-segment elevation as determined by the Investigator. m. Prior participation in this study. n. Prisoners or subjects who are involuntarily incarcerated. o. Subjects who are compulsorily detained for the treatment of either psychiatric or physical (e.g., infectious disease) illness.
    E.5 End points
    E.5.1Primary end point(s)
    CK-MB AUC through 80 hours post-PCI in the anterior STEMI cohort
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 491
    F.4.2.2In the whole clinical trial 1058
    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 Decision2009-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
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