Clinical Study Report - Calidad de Información CFR

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On site Monitoring : Eun-Kyoung, Oh / Ae-Jin, Lim Clinical research team / Lifecord Stat-Korea 14Fl. Paradise venture Bldg, #708-33 Yeoksam-dong, Gangnam-gu, Seoul, Korea Table 6.1: 1 List of all participating investigators and pharmacists Institutes Severance Hospital Asan Medical Center Chonnam National University Hospital 7. Introduction Principal investigators Yang-Soo, Jang Young-Hak, Kim Myung-Ho, Jeong Investigators Pharmacists Monitor Young-Guk, Ko Tae-Soo. Kang Dong-Hoon. Choi Seung-Jung. Park Seong-Wook. Park Jae-Joong. Kim Myeong-Ki. Hong Cheol-Whan. Lee Weon. Kim Ju-Han. Kim Young-Joon. Hong Ah-Young, Kim Si-Hyun, Park Ji-Won, Yoon Hye-Won, Lee Young-Sun, Ki Eun-Kyoung, Oh Ae-Jin, Lim Eun-Kyoung, Oh Ae-Jin, Lim Eun-Kyoung, Oh Ae-Jin, Lim Coronary diseases like angina pectoris and myocardial infarction have been rising very fast for the past 10 years, making it one of the leading causes of adult death in Korea 1) . Coronary disease clinically turns up as angina pectoris, ischemia without pain, myocardial infarction, or sudden death. In the past coronary artery bypass surgery was one of the main medical procedures, but in recent years PCI is the one. After PCI acute complications (about 5%) such as tunica intima dissection, thrombogenesis, or vasoconstriction and chronic complications (10- 25%) like re-stenosis still remain issues. Platelet-mediated thrombosis is known to account for pathophysiology of acute coronary symptoms 3) and for acute vascular obstruction as well 4)-6) . Administrating asprin to patients who will undergo angioplasty reduces risk of acute vascular obstruction, but is relatively weak in inhibiting platelet aggregation. Ischemic symptom in 10 – 20% of high-risk patients treated with asprin is a persistent problem 7) . CSR_Clotinab_II 20 Ver. 1.0_Eng
Abciximab, one of platelet glycoprotein (GP) IIb/IIIa receptor blockers, was developed by Coller in 1985 and named as 7E3. It is a chimeric human monoclonal antibody 8) . Abciximab is a strong inhibitor against platelet coagulation 7) . It binds to platelet surface GP IIb/IIIa receptor competitively with adhesive molecules such as fibrinogen and von Willebrand etc. and blocks the final stage of platelet coagulation. Various large-scale studies have found that Abciximab improves outcome of PCI and diabetes, decreases the incidence of short-term or long-term death, and reduces Major Adverse Cardiac Event (MACE). Inserting anti- platelet 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 ® on the domestic market, it is expected that Clotinab has same efficacy to ReoPro ® as a platelet GP IIb/IIIa receptor inhibitor. 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. 8. Study objective The objective of this trial is to evaluate the efficacy and safety of Clotinab, an investigational drug, to prevent ischemic cardiac complications in high-risk patients who will undergo Percutaneous Coronary Intervention (PCI) 9. Investigational plan 9.1. Overall study design and plan - description This trial is to proceed in two stages. The first stage is a single arm, multi-centre, open-label, study of Clotinab. Thirty eligible patients are to be admitted in the first stage. The secod stage is a randomized multi-centre open-label clinical trial with 40 patients to be allocated to the Clotinab group and 30 to the ReoPro ® group. Data from the ReoPro ® group is used as a reference point for decision rule. No comparison between two treatment groups is intended. When the first first stage is over, safety and efficacy results are to be submitted to KFDA, and regardless of the results, the clinical trial is to continue CSR_Clotinab_II 21 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: Coordination investigator : Prof. Y
Page 23 and 24: Test items Study flow chart * Women
Page 25 and 26: (3) Culprit lesion in the bypass gr
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
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12. Safety evaluation Eighty-three
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Bleeding Number of Patients Table 1
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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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