NCT01047176已完成不适用
Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI With Drug Eluting Stent (DES) Implantation Who Take Statins
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 602
- 试验地点
- 1
- 主要终点
- To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
研究概览
简要总结
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina with indication to PCI
- •Hospitalization to Russian Cardiological Research Center (РКНПК) for PCI procedure with drug-eluting stents implantation
- •Statin therapy initiated for at least one month prior to PCI
- •Written informed consent provided prior the start of participation in the study.
排除标准
- •Subjects who are unwilling or unable to provide informed consent.
- •Presence of ACS during the current hospitalization
- •Severe CHF (NYHA III/IV) or LVEF<40 %
- •Stroke within 6 months before PCI
- •Acute or chronic inflammatory disease
- •Anti-inflammatory medications intake, with the exception of aspirin
- •Severe liver or muscle disease
- •Severe kidney disease / renal failure with creatinine > 3 mg/dl
- •History of oncologic disease
- •Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention
结局指标
主要结局
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
时间窗: 3 visits for 12 month (before and after PCI)
次要结局
- To evaluate prognostic factors (demographic, co-morbidity, smoking, LDL-C, inflammatory and cardiac markers) in patients undergoing PCI with drug eluting stent (DES) implantation who take statins and their association with PCI (MACCE) outcomes(3 visits for 12 month)
- To estimate Low Density Lipoprotein Cholesterol (LDL-C) target level achievement and lipid-lowering therapy details in patients taking standard lipid lowering therapy prior the PCI.(3 visits for 12 months)
- To estimate inflammatory markers (C-reactive protein (CRP) and Leukocytes) in patients prior and after PCI.(3 visits for 12 months)
- To estimate cardiac markers (Troponin I, brain natriuretic peptide (BNP)) in patients before PCI.(3 visits for 12 months)
- To study lipoprotein associated phospholipase A2 (Lp PLA2) in patients before PCI and its' association with PCI outcome.(3 visits for 12 months)
- To study the rate of early and late stent thrombosis according to ARC classification(3 visits for 12 months)
研究者
研究点 (1)
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