Evaluate the Efficacy and Safety of Pletaal (Cilostazol) in Subjects With Vasospastic Angina

Variant Angina Clinical Trial

— STELLA  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of PletaalÒ(Cilostazol) in Subjects With Vasospastic Angina (STELLA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444885
• Other study ID #: STELLA
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2011
• Last updated: July 13, 2012
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to Amlodipine (Calcium channel blocker).

Description:

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic exploratory Study.

The subject who has at least an episode of chest pain weekly despite Amlodipine 5mg once a day (qd) taking during 2 weeks will have treatment of Pletaal (Cilostazol) or Placebo for 4 weeks. Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (bid) during 2 weeks after dosing of Pletaal (Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal (Cilostazol) is used as the control medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female over the age of 20 and under the age of 80

2. Diagnosis of vasospastic angina

3. At least one episode of chest pain weekly during the Amlodipine run in period for 2 weeks

Exclusion Criteria:

1. Currently taking or has taken Cilostazol within the last 3 month before the screening.

2. Taking oral antiplatelet agents such as Aspirin, Clopidogrel after Amlodipine run-in period.

3. Oral anticoagulants such as Warfarin within the last a month before the screening.

4. Currently taking any of the following medications or has taken any of the following medications within the last a week before the screening:

• Other Calcium channel blockers than Amlodipine

• Beta-blocker, or Alpha-blocker

• Oral Nitrate, Nicorandil, except sublingual Nitroglycerin as required(PRN)

• Vitamin E preparations

• Estrogens

5. History of Myocardial infarction or Myocardial infarction by vasospastic angina at screening

6. History of life threatening vasospastic events such as ventricular tachycardia , ventricular fibrillation, or syncope

7. History of stroke, intracranial hemorrhage, or Transient Ischemic Attack(TIA)

8. Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis, vitreous hemorrhage, etc.) or such tendency (active peptic ulcer, hemorrhagic stroke within past 6 months, a case hemorrhage is suspected by wound for surgery within 3 months, proliferative diabetic retinopathy and uncontrolled hypertension)

9. History of clinically significant hypersensitivity to the substances of Cilostazol, Amlodipine, Nitroglycerin or dihydropyridine

10. Patients with severe aortic valvular stenosis

11. History of shock

12. Hypotension of diastolic pressure < 90 mmHg at screening

13. History of clinically significant hypersensitivity to the substances of Nitrates

14. Patients with severe anemia of Hemoglobin = 6.5 g/dl at screening

15. History of glaucoma

16. Electrocardiogram(ECG) abnormality precluding interpretation of ST change at screening

17. Congestive heart failure with less than 40% of left ventricular ejection fraction within the last 3 month before the screening or screening period

18. Atrial fibrillation or valvular heart disease, more than moderate severity

19. Suspected or identified spasm of left main coronary artery, result of coronary angiography or coronary angiography in the ergonovine induced coronary spasm provocation test

20. History of Coronary artery bypass graft(CABG) or percutaneous coronary intervention(PCI)

21. Tachycardia; Heart rate > 100 bpm, at Screening

22. Uncontrolled hypertension, defined as = 160 mmHg systolic or = 100 mmHg diastolic at Screening

23. Creatinine = 1.5 mg/dL at screening

24. Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal (ULN) at screening

25. Platelet < 100,000 mm3 at screening

26. QT prolongation defined as baseline QTc > 450 msec for males or > 470 msec for females at Screening.

27. Women who have the possible of pregnancy, or positive urine or blood pregnancy test at screening

28. Women who are not using a reliable method of birth control, who are pregnant, or who are breast-feeding

29. Drug compliance of Amlodipine < 80% during the Amlodipine run in period for 2 weeks

30. Otherwise judged by the investigator to be inappropriate for inclusion in the trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Variant Angina

Intervention

Drug:
• Placebo
2 weeks treatment of Cilostazol 100mg, or placebo oral tablets bid after 2 weeks treatment of Cilostazol 50mg, or placebo oral tablets bid (Total 4 weeks)

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	ChungNam Univ. Hospital	DaeJeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gyongsang National University Hospital	Jinjoo
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Pusan National University Yansan Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of the chest pain frequency	Collect the chest pain frequency data related with vasospastic angina episodes by subject diaries.; Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate.	A week before IP dosing and the final a week after IP dosing (average 6weeks)	Yes
Secondary	The chest pain frequency, the pain intensity, nitroglycerin consumption of the final a week after IP dosing from a week before IP dosing	Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate. The subject who has no chest pain will be regarded as the total pain intensity and the average pain intensity are '0'. The subject who has taken no nitroglycerin will be regarded as taking '0' tablet.	A week before IP dosing and the final a week after IP dosing (average 6weeks)	Yes