The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Lipid profile changes
研究概览
简要总结
Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.
详细描述
Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute coronary syndrome (ST elevation and non ST elevation)
- •Early invasive strategy
排除标准
- •contraindication to statin therapy
- •refusal of consent
结局指标
主要结局
Lipid profile changes
时间窗: up to 1 month
Changes from baseline in cholesterol values
Platelet count
时间窗: up to 1 month
Changes from baseline in platelet count
Platelet volume
时间窗: up to 1 month
Changes from baseline in platelet volume
Platelet aggregation profile
时间窗: up to 1 month
Changes from baseline in platelet reactivity (Verify Now)
Inflammatory profile changes
时间窗: up to 1 month
Changes from baseline in CRP values
Acute renal function changes
时间窗: Within 72 hours after hospital admission
Changes in creatinine and/or cystatine values
次要结局
- Renal function changes(Changes from baseline at 1 month)
- Major cardiovascular adverse events(up to 12 months)
- Major adverse cardiovascular and renal adverse events(up to 1 month)
研究者
Anna Toso
Principal Investigator
Centro Cardiopatici Toscani