Clinical Study Report - Calidad de Información CFR

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9.2. Discussion of study design, including the choice of control groups Inserting antiplatelet GP IIb/IIIa DNA into Chinese hamster’s ovary cell produces Clotinab, a product made in ISU ABXIS CO., LTD. Since it contains identical active ingredient as ReoPro ® , a platelet GP IIb/IIIa receptor inhibitor, which is already on the domestic market, Clotinab is expected to have the same efficacy as ReoPro ® . Therefore, this theraputic and exploratory clinical trial was designed to investigate the preventive effect on ischemic heart complications and safety of adjuvant use of Clotinab with asprin and heparin in high-risk acute coronary thrombotic patients who will undergo PCI. 9.3. Selection of study population 9.3.1. Inclusion criteria (1) Patients aged between 19 and 80 (2) Patients meeting one of the following conditions and who will undergo PCI: 1) Patients showing ischemic ST change in electrocardiogram among patients as well as refractory to drug treatment in resting phase or with recurrent angina pectoris 2) Post-infarction angina patients within 7 days from myocardial infarction attack refractory to drug treatment and showing ischemic ST change in electrocardiogram 3) Acute Q-Wave myocardial infarction within 12 hours after the attack, which requires direct intervention procedure 4) Acute Q-Wave myocardial infarction within 12 hours after the attack, which requires another rescue intervention after failure to thrombolytic therapy 5) Classification of vascular lesions according to the coronary arteriostenosis (ACC/AHA) criteria defined by angiography* - Two type B lesion characteristics - One type C lesion characteristic - Females aged over 65 with one Type B lesion characteristic - Diabetics with one lesion Type B characteristic (3) Subjects who have signed the informed consent form 9.3.2. Exclusion criteria (1) Patients to whom PCI cannot be administered within 24 hours from receiving the investigational product (2) Occlusion of the left main coronary artery is ≥ 50 % and bypass surgery is applicable CSR_Clotinab_II 24 Ver. 1.0_Eng
(3) Culprit lesion in the bypass graft (4) Major surgery or trauma within recent 6 weeks (5) Gastrointestinal or genitourinary bleeding of clinical significance within recent six weeks (6) History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit (7) Patients who require oral anticoagulants during the trial (8) Patients who have been administrated oral anticoagulants within 7 days (permissible if prothrombin time is controlled to ≤ 1.2 times before the procedure) (9) Severe uncontrollable hypertension (SBP > 180mm Hg or DBP > 100mm Hg) (10) Retinal hemorrhage within recent 6 weeks (11) Bleeding diathesis (i.e. internal bleeding or hemostatic disorder) (12) Thrombocytopenia (< 100,000 cells/mL) (13) Hypersensitivity to the test drug or murine protein, or history of hypersensitivity (14) Patients who had participated in other clinical trial within 30 days (15) Intracranial neoplasm, arteriovenous malformation, or aneurysm (16) History or diagnosis of vasculitis (17) Severe renal dysfunction (Creatinine is two times higher than the upper limit of normal of each center.) or hepatic disorder (GOT, GPT is three times higher than the upper limit of normal.) (18) Pregnancy, breast feeding, or females of childbearing age without using a proper contraceptive (19) Alcohol addictive, drug misuse or abuse, or patients who are not able to participate in the trial due to psychological or emotional problem (20) Patients whose voluntary participation in the trial may be influenced by the investigator (21) Patients who can’t take antiplatelet drugs (22) Patients who might die of other disease than cardiac disease during the trial (23) Patients who the investigator judges ineligible due to other than the situations above (24) Use of dextran intravenously before PCI or intent to use it during PCI 9.3.3. Removal of patients from therapy or assessment Subjects might drop/be discontinued due to the following reasons: (1) Dropout Criteria 1) When a subject or legal agent withdraws the consent (The withdrawal will not jeopardize suject’s future treatment or care.) 2) Failure to follow up after treatment with the investigational medication CSR_Clotinab_II 25 Ver. 1.0_Eng
Page 1 and 2: Clinical Study Report A multicentre
Page 3 and 4: 1.2. Signature page WRITER CSR Writ
Page 5 and 6: Sponsor: ISU ABXIS Co.,Ltd Study nu
Page 13 and 14: 9.5.1. Efficacy and safety measurem
Page 15 and 16: LIST OF IN-TEXT TABLES & FIGURE TAB
Page 17 and 18: 4. List of abbreviations and defini
Page 19 and 20: Coordination investigator : Prof. Y
Page 21 and 22: Abciximab, one of platelet glycopro
Page 23: Test items Study flow chart * Women
Page 27 and 28: Product Name Clotinab Generic Name
Page 29 and 30: Biostatisitician Kyoung-A Kim, Byeo
Page 31 and 32: The primary efficacy endpoint is th
Page 33 and 34: 9.5.1.2. Safety measurement assesse
Page 35 and 36: v) None: AE occurs independently fr
Page 37 and 38: 9.7.1. Statistical and Analytical P
Page 39 and 40: lood cell (RBC) infused within 48 h
Page 41 and 42: H0 : p ≥ 0.2 versus HA : p < 0.2
Page 43 and 44: Table 10.1:1 Disposition of Subject
Page 45 and 46: Table 10.2:1 Listing of subjects wi
Page 47 and 48: 1) 2) 3) 4) next 53 patients with r
Page 49 and 50: Max 77.0 77.0 77.0 Height (cm) N 82
Page 51 and 52: Table 11.2.1:5 Subject demographics
Page 53 and 54: Table 11.2.1:6 Subject demographics
Page 55 and 56: Medical history data are summarized
Page 57 and 58: Table 11.2.2:3 Pre-trial interview
Page 59 and 60: Table 11.2.2:5 Medical History (FAS
Page 61 and 62: 11.3. Efficacy results, tabulations
Page 63 and 64: Angina (%) Table 11.3.1:2 Major Adv
Page 65 and 66: Angina (%) Emergency revascularizat
Page 67 and 68: Visit 12hr Baseline C.I. : confiden
Page 69 and 70: Visit 12hr Baseline Table 11.3.2:4
Page 71 and 72: Visit 12hr Table 11.3.2:6 The chang
Page 73 and 74: 12. Safety evaluation Eighty-three
Page 75 and 76:
Bleeding Number of Patients Table 1
Page 77 and 78:
Table 12.2:5 Number of patients wit
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Hb Hct Table 12.4:1 Hb/Hct - Clotin
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egion-specific) or C region (consta
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Clotinab (N=83) ReoPro ® (N=40) Ta
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Body system Blood and lymphatic sys
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Body system CSR_Clotinab_II 87 Ver.
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Table 12.6.2:2 Number observed and
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Body system CSR_Clotinab_II 91 Ver.
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The subject Y056 (KMC, male, 57 yea
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Subject ID Table 12.7:2 Subjects wi
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12.8. Clinical laboratory evaluatio
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13. Discussion and overall conclusi
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The intention of this clinical stud
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14. Reference list (1) 혈소판
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(28) Willerson JT, Golino P, Eidt J
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Table 15. 1 Medication administered
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Table 15. 2 Concomitant medication
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Table 15. 3 Medication - administer
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Table 15. 5 Medication - administer
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Table 15. 7 Disposition of subjects
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Table 15. 9 The rate of adverse eve
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Body system/Preferred term Number o
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Table 15. 10 Number observed and ra
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Body system Gastrointestinal disord
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General disorders and administratio
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General disorders and administratio
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Body system Hypoaesthesia 3(3.61%)
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Body system Vascular disorders Ging
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Body system Gastrointestinal disord
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Body system Face oedema 1(2.50%) Y0
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Body system Psychiatric disorders S
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Subject list of all adverse events
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Table 15. 13 Laboratory Data WBC RB
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PLT Neutro. (seg) Table 15. 13 Labo
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Table 15.13 Laboratory Data (Contin
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Table 15. 13 Laboratory Data (Conti
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SGOT (AST) SGPT (ALT) Table 15. 13
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Table 15. 14 Cardiac Marker Clotina
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Table 15. 15 Urinalysis-Clotinab IT
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Table 15. 16 Urinalysis-ReoPro ® I
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Table 15. 17 Coagulation ITEM(APTT
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Table 15. 18 Vital sign (continued)
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Table 15. 19 Physical examination-C
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Table 15. 20 Physical examination -
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Table 15. 21 Listing of subjects wi
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NO. Subject ID Group Comment 54 Y03
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Deviation type N : no ACT measureme
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Clinical Study Report - Calidad de Información CFR

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