Clinical Study Report - Calidad de Información CFR

The clinical trial was activated on May 17, 2005. First thirty eligible patients were to be
admitted to the Clotinab group without randomization. However, the PCI procedure failed in
one patient (C003). One additional patient was admitted to the Clotinab group, making the size
of the first stage thirty-one. Afterwards ninety-three patients were randomized between
Clotinab and ReoPro ® . A total of 124 patients were admitted into the trial. Efficacy and safety
results from the first stage were submitted as an interim report to the KFDA in August 2005.
The screening period was 1 day to 2 weeks. Day 1 is the date of baseline examination and PCI
administration. The screening examination may replace the baseline examination. Patients were
followed four weeks post PCI and treatment.
Ten minutes to six hours prior to PCI, 0.25 mg/kg of Clotinab was administered IV bolus,
followed by a 12-hour infusion of 0.125 mg/kg/min (Max 10 ug/min) dissolved in sterile saline of
0.9 % or dextrose of 5 % .
While hospitalized for recuperation from the PCI procedure, patients were examined according
to the protocol. Post PCI assessment of efficacy and safety was performed at 12h, 24h, day 3,
and either on the date of discharge or one day before the discharge. If day 3 falls on the date
of discharge, the assessment of the date of discharge was not recorded in the CRF.
Patients made the return visit on day30(+7) to be examined according to the protocol and
evaluated for efficacy and safety. Aspirin and heparin were prescribed together, and other oral
anticoagulants as well as Dextran were prohibited throughout the trial period. All the
concomittant medications and all the observed adverse events were recorded in the CRF.
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