Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina (STELLA_Ext)

A Multicenter, One Group, Open-label Study to Evaluate the Safety and Efficacy of Pletaal(Cilostazol) as BID for up to 24 Weeks Exposure in Subjects With Vasospastic Angina (STELLA Extension)

This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of MFDS.

Each subject will participate around 26 weeks, which include the 24 weeks treatment period and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.

Study Overview

• Status: Completed
• Conditions: Vasospastic Angina
• Intervention / Treatment: Drug: Cilostazol

Detailed Description

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 Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.).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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 626-770
    • Yangsan Busan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Subjects who completed 021-KOA-1301i clinical trial
3. 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)
4. 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:

1. Subjects who fell under one of the exclusion criteria at the time of enrollment for 021-KOA-1301i

2. 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.)
3. Subjects who are currently using any of the medications contraindicated in 021-KOA-1301i (excluding the investigational product of 021-KOA-1301i) at baseline

4. 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
5. Pulse rate exceeding 100 bpm when measured for vital signs at baseline: Tachycardia
6. Hypotension with systolic pressure < 90mmHg at baseline
7. Uncontrolled hypertension defined as systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at baseline
8. QT prolongation defined as QTcB > 450 msec for men and QTcB > 470 msec for women at baseline
9. Women of childbearing potential with positive pregnancy test at baseline
10. Women who do not agree to practice a contraceptive measure, or are pregnant or lactating
11. Subjects who are not expected to have the potential to benefit from additional administration of Cilostazol, according to the investigator's judgment
12. Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cilostazol; Cilostazol 50mg and 100mg	Drug: Cilostazol; Oral, Bid, 24 weeks; Other Names: Pletaal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period	Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary 1	Change/rate of change in the frequency of chest pain in the final 1week/2 weeks after the 24-week treatment period compared to those in the final 1 week/2weeks of Amlodipine run-in period in 021-KOA-1301i	24 week
secondary 2	Mean change in the intensity of chest pain in the final 1 week/2 weeks after the 24-week treatment period compared to that in the final 1 week/2weeks of Amlodipine run-in period in 021-KOA-1301i	4 weeks
secondary 3	4-week cumulative rate of subjects withdrawn due to lack of efficacy	4 weeks

Collaborators and Investigators

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Junghong Kim, MD, Yangsan Busan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (ESTIMATE): March 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Treatment for vasospastic angina
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina, Unstable; Angina Pectoris; Angina Pectoris, Variant; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: 021-KOA-1302i