None listed
Conditions
Interventions
Drug : 1. Cylostan tablet 200mg (Cylostazol), 1 tablet, QD, PO, 4 weeks (30T)
2. Isobid tablet (isosorbide nitrate), 1 tablet, BID, PO, 4 weeks (60T)
By comparing nitrate and head-to-head, which are
Sponsors
Pusan National University Yangsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 20 to 80 years 2) A person diagnosed with a variant angina based on the following criteria ? Resting anginal chest pain ? Documented coronary vasospasm: A~C ? ?? A. CAG (Reversible vasospasm) a. Provocation Test (Use of intravenous ergonovine): positive B. Echocardiogram a. Provocation Test (Use of intravenous ergonovine): positive C. Routine ECG or 24h ECG Holter monitoring a. Transient ST-T wave ? Exclusion of significant coronary arterial stenosis: A~D ? ?? A. CAG: No culprit lesion (<50% luminal narrowing) B. CT-coronary angio: No significant lesion (<50% stenosis) C. TMT: Negative D. Thalium SPECT: Normal uptake 3) Established and conducted by the responsible physician according to the characteristics of the clinical trial drug Clinical laboratory tests (hematology test, blood chemistry test, serum test, urine test, etc.) and It is suitable as a test subject as a result of tests performed during screening such as X-ray Judge 4) The purpose, contents, drug characteristics, and expected adverse reactions A person who has signed a consent form after freely understanding and understanding it
Exclusion criteria
Exclusion criteria: 1) The site where spasm occurs has lesions with lumen stenosis of 50% or more mixed angina 2) When vasospasm, ischemia of a large area equivalent to the left main bronchus When triggered 3) Patients with chronic renal failure (serum creatinine> 2mg / dL) 4) Patients with a history of hypersensitivity to THIS DRUG and its components 5) Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper digestive vascular hemorrhage, urinary tract hemorrhage, Hemoptysis, vitreous hemorrhage, etc. or such predisposition (active digestive ulcer, last 6 months) Hemorrhagic stroke within, surgical operation within 3 months, proliferative diabetic retinopathy, Patients with uncontrolled hypertension) 6) Patients with congestive heart failure (e.g. EF <40%) 7) glaucoma patients 8) Patients with hypersensitivity or history of nitrate preparations 9) Patients with severe hypotension and psychogenic shock 10) Patients with severe anemia 11) Patients with head trauma or brain hemorrhage 12) Acute myocardial infarction patient with low left ventricular filling pressure 13) Hypertrophic obstructive cardiomyopathy patients 14) patients with deadlock pericarditis 15) Those who are taking conventional medicines due to mutant angina 16) Pregnant and lactating women and pregnant women 17) The person in charge of the examination judges that it is not suitable for participation in the examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest pain score;NTG use count;Change in pain duration;Adverse Events (headache, bleeding, gum hyperplasia, hypotension, edema) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in chest pain score | — |
Countries
Korea, Republic of
Contacts
Public ContactBo Kyung Kim
Pusan National University Yangsan Hospital
Outcome results
None listed