Comparison of a new Cilostazol treatment versus a Conventional therapy with Isosorbide mononitrate for clinical effectiveness in patients of variant angina: Prospective, Single center, Randomized, Open label, Controlled Trial

Pusan National University Yangsan Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新: 2020年8月18日

适应症

试验速览

暂无简介。

•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
•4) The purpose, contents, drug characteristics, and expected adverse reactions
•A person who has signed a consent form after freely understanding and understanding it

•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

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