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
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005064
- Lead Sponsor
- Pusan National University Yangsan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chest pain score;NTG use count;Change in pain duration;Adverse Events (headache, bleeding, gum hyperplasia, hypotension, edema)
- Secondary Outcome Measures
Name Time Method Change in chest pain score