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临床试验/NCT04087200
NCT04087200招募中不适用

The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome

Centro Cardiopatici Toscani1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2016年12月1日最近更新:
适应症

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

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

发起方
Centro Cardiopatici Toscani
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Toso

Principal Investigator

Centro Cardiopatici Toscani

研究点 (1)

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