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

NCT ID: NCT01444885

Last Updated: 2012-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-07-31

Brief 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).

Detailed 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.

Conditions

Variant Angina

Keywords

Variant angina; Cilostazol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cilostazol

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).

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Amlodipine; Nitroglycerin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

June Hong Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yansan Hospital

Locations

Keimyung University Dongsan Medical Center

Daegu, , South Korea

ChungNam Univ. Hospital

Daejeon, , South Korea

Gangneung Asan Hospital

Gangneung, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Gyongsang National University Hospital

Jinjoo, , South Korea

Dong-A University Hospital

Pusan, , South Korea

Pusan National University Yansan Hospital

Pusan, , South Korea

Asan Medical Center

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

References

Shin ES, Lee JH, Yoo SY, Park Y, Hong YJ, Kim MH, Lee JY, Nam CW, Tahk SJ, Kim JS, Jeong YH, Lee CW, Shin HK, Kim JH. A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in patients with vasospastic angina. Heart. 2014 Oct;100(19):1531-6. doi: 10.1136/heartjnl-2014-305986. Epub 2014 Jun 16.

Reference Type: DERIVED

PMID: 24934484 (View on PubMed)

Other Identifiers

STELLA

Identifier Type: -

Identifier Source: org_study_id