Efficacy Study of Atorvastatin to Treat Variant Angina
试验速览
- 阶段
- 4 期
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Ergonovine provocation test 24hrs later after admission
研究概览
简要总结
The objective of this study is to evaluate effect of statin treatment for vasospastic angina.
详细描述
Vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. The precise mechanisms have not been established, but a reduction in NO (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested.
Impaired FMD(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies.
So, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vasospastic angina or spontaneous spasm during coronary angiography (Vasospastic angina is defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or EKG change; Spontaneous spasm is defined as TIMI flow grade 0-2 of coronary artery without ergonovine injection)
- •Normal or insignificant lesion (diameter stenosis <50%) on coronary angiography
排除标准
- •Elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- •Significant lesion( diameter stenosis ≥50%) documented in coronary angiography
- •Pregnancy
- •Prior percutaneous coronary intervention or coronary artery bypass surgery
- •Previous statin use
- •Impaired renal function with serum creatinine ≥ 2.0 mg/dl
- •Severe left ventricular dysfunction ( LVEF ≤ 30% on echocardiography)
研究组 & 干预措施
A
Atorvastatin group
干预措施: atorvastatin (Drug)
结局指标
主要结局
Ergonovine provocation test 24hrs later after admission
时间窗: 1 year later
次要结局
- Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)(1year later)