Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina

A Multicenter, One group, Open-label Study. Cilostazol will be treated for additional 24 weeks to the subject who had completed 021-KOA-1301i study. PletaalÒ(Cilostazol) is taken 100mg oral tablets bid during 2 3weeks after dosing of PletaalÒ(Cilostazol) 50mg oral tablets bid during 1 week. The dose can be adjusted by investigator's discretion during the study and the detailed method is described in the Protocol. Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.). Subjects who participated in this trial will have 2 weeks follow-up after study completion.

Inclusion criteria

• Male or female subjects aged 20 to 80 years, and subjects whose age at the time of enrollment was 80 in 021-KOA-1301i clinical trial and is 81 in this clinical trial
• Subjects who completed 021-KOA-1301i clinical trial
• Women of childbearing potential with negative pregnancy test at enrollment and who agree to practice a contraceptive measure throughout the clinical trial (e.g., hormonal contraceptives, intrauterine devices, condom + spermicidal agents, diaphragm + spermicidal agents, and partner's infertility)
• Subjects who signed a written agreement indicating that they were given full explanations of the clinical trial and are willing to participate in the clinical trial

Exclusion criteria

• Subjects who fell under one of the exclusion criteria at the time of enrollment for 021-KOA-1301i
• Subjects who reported any of the following events, which fall under the exclusion criteria for KOA-1301i, between the initiation of 021-KOA-1301i participation and enrollment visit for 021-KOA-1302i

• Myocardial infarction or myocardial infarction induced by vasospastic angina
• Life-threatening vasospastic episodes (e.g., ventricular tachycardia, ventricular fibrillation, or syncope)
• Stroke, intracranial hemorrhage, or transient ischemic attack (TIA)
• Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)
• Subjects who are currently using any of the medications contraindicated in 021-KOA-1301i (excluding the investigational product of 021-KOA-1301i) at baseline
• Subjects who meet the following criteria for baseline laboratory findings

• severe anemia with hemoglobin ≤6.5 g/dl at baseline
• Creatinine level ≥ 1.5 mg/dL at baseline
• AST or ALT >3x ULN at baseline
• Platelet count < 100,000mm3 at baseline
• Pulse rate exceeding 100 bpm when measured for vital signs at baseline: Tachycardia
• Hypotension with systolic pressure < 90mmHg at baseline
• Uncontrolled hypertension defined as systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at baseline
• QT prolongation defined as QTcB > 450 msec for men and QTcB > 470 msec for women at baseline
• Women of childbearing potential with positive pregnancy test at baseline
• Women who do not agree to practice a contraceptive measure, or are pregnant or lactating
• Subjects who are not expected to have the potential to benefit from additional administration of Cilostazol, according to the investigator's judgment
• Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial