NCT01372839Unknown4 期
The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
研究概览
简要总结
Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.
详细描述
This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.
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
- None
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
- •18-85 years old
- •Patients with clinical diagnosis of ACS
- •Evidence of a personally signed and dated informed consent document
排除标准
- •Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
- •LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
- •Endstage congestive heart failure, or LVEF < 30%
- •Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
- •Myopathy or increased creatine kinase (CK>2 UNL)
- •Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
- •Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
- •Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
- •Pregnancy, lactation, or child bearing potential women without any effective contraception
- •Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
- •Participating in other interventional clinical trails using drugs or devices
- •Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
研究组 & 干预措施
Atorvastatin
Active Comparator
80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
干预措施: Atorvastatin (Drug)
Usual care
Other
statin dose should not be higher than that described in exclusion criteria.
干预措施: Statin (Drug)
结局指标
主要结局
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
时间窗: 30-day
次要结局
- Post-procedural change of inflammatory biomarkers (hs-CRP)(24h)
- Morbidity of CIN(48h)
- Elevation of ALT, AST and CK(6 months)
- Number of Participants with Adverse Events(6 months)
- Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events(6 months)
- serum adiponectin concentration(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCIST-elevation Myocardial Infarction(STEMI)NCT01334671General Hospital of Chinese Armed Police Forces150
招募中
不适用
The effect of high dose statins (Simvastatin 80 mg) on vascular inflammation in the abdominal aneurysm.Abdominal Aortic AneurysmNL-OMON24165eiden University Medical Center25
Unknown
4 期
Aspirin Mono Therapy 12-months After Drug-eluting Stents ImplantationDrug-eluting Stent (DES)NCT01557075Yonsei University2,000
已完成
不适用
Livalo Acute Myocardial Infarction StudyAcute Myocardial InfarctionNCT00805714JW Pharmaceutical1,128
进行中（未招募）
不适用
Evaluation of Statin Therapy- Safety, Effect and Toxicity Mechanisms.Frequency of side effects in patients treated with HMG CoA reductase inhibitors.MedDRA version: 8.1Level: LLTClassification code 10058108Term: DyslipidaemiaEUCTR2006-004686-34-SEKarolinska University Hospital