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临床试验/NCT02561845
NCT02561845撤回不适用

Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in Percutaneous Coronary Intervention Patients

AstraZeneca0 个研究点开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
AstraZeneca
主要终点
Change from baseline Low density lipoprotein-cholesterol (LDL-C) at 30 days

研究概览

简要总结

Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and the population is well suited to demonstrating rosuvastatin's low density lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, high density lipoprotein-cholesterol (HDL-C), Triglyceride (TG), and non-HDL-C) and lipid goal attainment according to recent guidelines.

详细描述

The number of patients receiving Percutaneous Coronary Intervention (PCI) is rapidly increasing in China. In 2013, about 450,000 Chinese patients received PCI, most of whom suffered from coronary heart disease (CHD), especially acute coronary syndrome (ACS). ACS is associated with an increased risk of cardiovascular mortality and recurrent cardiac events, underscoring the importance of identifying treatments that minimize this risk.The Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial suggested a benefit of lipid lowering with high-dose atorvastatin in patients with ACS. A meta-analysis of statin use in patients with ACS confirmed the benefits of early high-dose statin administration in decreasing recurrent myocardial ischemia, which suggested the clinical benefit and safety of statins were dose and statin dependent. The updated National Cholesterol Education Program Adult Treatment Panel III guidelines recommend that intensive therapy should be considered for all patients admitted to hospital for an ACS. Two meta-analyses have shown that early intensive statin therapy in patients with ACS is associated with a reduced rate of death and cardiovascular events. In the PROVE IT study, comparing atorvastatin 80 mg with pravastatin 40 mg, a significant reduction in major adverse clinical events was observed in favour of more intensive statin treatment. In that study, the median concentration of low-density LDL-C was lowered from 106 mg/dL to 62 mg/dL in the atorvastatin 80 mg group. More recently, the 2011 European Society of Cardiology (ESC)/ European Arterial Sclerosis Association (EAS) guideline for the management of dyslipidemia recommended patients with ACS are very high CV risk patients and should achieve LDL-C level <70 mg/dl or 50% reduction. In 2011 American College of Cardiology Foundation (ACCF) / American Heart Association (AHA) / (cardiovascular angiography and intervention Association)/ Association of Cardiovascular angiography and intervention (SCAI) Guideline for PCI, statin therapy which lowers LDL to <70mg/dL in very high-risk patients is recommended (IIa, B). The latest China ACS consensus also recommends using the highest dose statin treatment for the acute phase and to attain an LDL-C level of 1.8 mmol/L or 50% reduction compared with baseline in long-term treatment. However, there are very limited Chinese data demonstrating the current situation of lipid management (LDL-C on-goal rate) by different statins in real-world clinical practice.

Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, HDL-C, TG, and non-HDL-C) and lipid goal attainment according to recent guidelines.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

rosuvastatin group

patients who received rosuvastatin

干预措施: rosuvastatin (Drug)

结局指标

主要结局

Change from baseline Low density lipoprotein-cholesterol (LDL-C) at 30 days

时间窗: Blood samples are collected pre-dose, 30 days post dose

by assessment of statins on the on-goal rate of LDL-C treatment of patients underwent PCI

次要结局

  • number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 3 months(Blood samples are collected at 3 months post dose)
  • Change from baseline lipid level at 3 months(Blood samples are collected pre-dose, 3 months post dose)
  • Change from baseline lipid level at 6 months(Blood samples are collected pre-dose, 6 months post dose)
  • Change from the baseline statin dose at 12 months(The dose of the treated statin is collected up to 12 months)
  • Change from baseline lipid level at 30 days(Blood samples are collected pre-dose, 30 days post dose)
  • Change from baseline lipid level at 12 months(Blood samples are collected pre-dose, 12 months post dose)
  • number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 30 days(Blood samples are collected at 30 days post dose)
  • number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 12 months(Blood samples are collected at 12 months post dose)
  • number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 6 months(Blood samples are collected at 6 months post dose)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

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