COmparison and Modification in Neointimal Pattern Assessed by Optical Coherence Tomography With High Versus Moderate Efficacy Statin Treatment After Drug Eluting Stent Implantation: COMPASS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of neointimal patterns assessed by 1-year followed OCT
研究概览
简要总结
This study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that Atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in patients with DES implantation.
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
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 20 years old
- •Patients who received OCT related to clinical needs or the end point of other study
- •Patients who received DES within 1 year before OCT evaluation
- •Patients with homogenous or hetero neointimal pattern by OCT
- •Non-statin user and moderate or low efficacy statin user
排除标准
- •Refuse to participate
- •Contraindication to statin treatment
- •Women with current or potential childbearing
- •Life expectancy <1 year
- •High efficacy statin user (Atorvastatin 80mg or Rosuvastatin 20mg)
研究组 & 干预措施
High efficacy statin group (homogeneous)
homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
干预措施: Atorvastatin 40mg (Drug)
Low efficacy statin group (homogeneous)
homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group
干预措施: pravastatin 20 mg (Drug)
结局指标
主要结局
Change of neointimal patterns assessed by 1-year followed OCT
时间窗: at 1 year
Qualitative neointimal pattern measured by OCT such as restenotic tissue structure
次要结局
- stent coverage and neointimal thickness(at 1 year)
- Major adverse cardiac events(at 1 year)