Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of the effect on ventricular remodeling
研究概览
简要总结
STEMI is a serious type of coronary heart disease, which is a major cause of disability and death. Morphologically the key feature of remodeling is myocyte hypertrophy, myocyte loss from necrosis or apoptosis, as well as interstitial cell growth especially fibroblast proliferation leading to myocardial fibrosis .
Elevated serum LDL-cholesterol concentrations play a proatherogenic role by stimulating inflammation and oxidative processes.
Statins have been documented to retard fibrosis and ventricular hypertrophy by the cessation of myofibroblast activity. Clinical studies have proven that statins not only regulate lipids but also improve myocardial fibrosis, regulate cell proliferation and apoptosis, regulate ventricular remodeling, and protect the myocardium
详细描述
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital.
- Serum samples will be collected from patients at the time of admission for measuring the biomarkers.
- Echocardiogram also will be obtained at the time of admission.
- All enrolled patients will be divided into two group to receive either Atorvastatin (40 mg) or Rosuvastatin (20mg).
- All patients will be followed up during 3 months' period. At the end of 3 months, Serum samples will be collected from patients for measuring the biomarkers and Echocardiogram will be repeated.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion, and recommendations will be given.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Electrocardiogram showed abnormal elevation of the ST segment.
- •First myocardial infarction occurred.
- •The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h.
排除标准
- •Severe cardiac insufficiency.
- •Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level).
- •Renal insufficiency (creatinine clearance rate <30 mL/min).
- •Addition of others blood lipid lowering and antioxidant drugs during follow up period.
- •Familial hypercholesterolemia.
- •Malignant tumor.
- •Immune system disease.
- •Acute infectious disease.
- •Hypersensitivity to rosuvastatin and Atorvastatin.
研究组 & 干预措施
Rosuvastatin group
patients will receive Rosuvastatin orally (20 mg) at night once daily
干预措施: Rosuvastatin 20 mg (Drug)
Atorvastatin group
patients will receive Atorvastatin orally (40 mg) at night once daily
干预措施: Atorvastatin 40mg (Drug)
结局指标
主要结局
Evaluation of the effect on ventricular remodeling
时间窗: 3 months
MMP9,sST2 and CRP level will be measured and monitoring the change in their levels Echocardiogram will be obtained and monitoring the change in echocardiogram indexes.
次要结局
- Evaluation of the effect on lipid parameters and liver enzymes(3 months)