Effects of High- or Moderate-Dose Statin on 1-Year Major Adverse Cardiovascular Events (MACE) Post Percutaneous Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- major adverse cardiovascular events (MACE)
研究概览
简要总结
In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded
详细描述
In this randomized double-blind clinical trial, the study population was all patients with a recent history of PCI who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. In the first visit, patients were randomly divided into two groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one year. Then, the participants were evaluated in terms of MACEs, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial Infarction, subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two groups
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Group A, group B
入排标准
- 年龄范围
- 52 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who have undergone PCI due to chronic stable angina
排除标准
- •Patients with acute coronary syndrome
- •Primary LDL>190 mg/DL
- •Patients who developed statin-induced myopathy or rhabdomyolysis
- •Persistent increase in hepatic enzyme levels or hepatic failure
- •Pregnancy and breast feeding
- •Statin hypersensitivity
- •Patients with history of multiple atherosclerotic events
- •Patients who received high intensity statin before the study enrollment.
研究组 & 干预措施
moderate dose statin
Patients 1 month post PCI, allocated to 5 mg rosuvastatin per day
干预措施: moderate statin dose (Drug)
high dose statin
patients 1 month post PCI, allocated to 40 mg rosuvastatin
干预措施: high dose statin (Drug)
结局指标
主要结局
major adverse cardiovascular events (MACE)
时间窗: 1 year
major adverse cardiovascular events
serum level of HS-CRP
时间窗: 1 year
次要结局
未报告次要终点
研究者
Javad Kojuri
Professor
Shiraz University of Medical Sciences