Clinical Study Report - Calidad de Información CFR

Sponsor: ISU ABXIS Co.,Ltd
Study number: Clotinab_II
Version date: 08-MAR-2006
Name of finished drug : Name of activeingredient : Study period :
Clotinab Abciximab 17-MAY-2005 ~ 01-DEC-2005
Inclusion /
Exclusion
criteria
(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
CSR_Clotinab_II 6
Ver. 1.0_Eng