NCT01674686Unknown4 期
A Prospective, Single-center, Randomized Study to Evaluate the Effect of Sarpogrelate, a Selective Serotonin Receptor Antagonist, and High Dose Statin on the Reduction of Coronary Spasm in the Patients With Variant Angina
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ergonovine provocation test 12months later
研究概览
简要总结
The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
- •Angiographically proven coronary spasm; TIMI flow < 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.
排除标准
- •Cardiac arrest by coronary spasm
- •Left main coronary spasm
- •Significant fixed coronary artery stenosis; Diameter stenosis > 70% in the major epicardial artery by coronary angiography
- •Left ventricular ejection fraction < 30%
- •Coagulation disorders or bleeding tendency (Platelet count < 50k, PT INR > 2.0)
- •Significant liver disease (AST or ALT > 100 U/ml)
- •Renal failure (S-Cr > 2.0 mg/dl)
- •hypersensitivity for statin
- •Pregnancy
研究组 & 干预措施
A
Experimental
Sarpogrelate versus placebo
干预措施: Sarpogrelate (Drug)
B
Experimental
Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Ergonovine provocation test 12months later
时间窗: 1 year later
次要结局
- C-reactive protein lever 12months later(1 year)
研究者
Hyeon-Cheol Gwon
professor
Samsung Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery DiseaseCoronary Artery DiseaseNCT02607436Seoul National University Bundang Hospital40
终止
3 期
Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel SyndromeConstipation-Predominant Irritable Bowel SyndromeNCT00742872American University of Beirut Medical Center41
已完成
1 期
Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release FormulationHealthyNCT01841086Korea United Pharm. Inc.50
已完成
3 期
Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' StudyDiabetes MellitusCoronary Artery DiseaseRenal Insufficiency, ChronicNCT02294643Seoul National University Bundang Hospital220
已完成
不适用
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress DisorderChronic Posttraumatic Stress DisorderNCT01024140Northern California Institute of Research and Education16