NCT01173939终止不适用
Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension
Positive Trial Group309 个研究点 分布在 1 个国家目标入组 10,000 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
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10,000
- 试验地点
- 309
- 主要终点
- MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
研究概览
简要总结
The study is being conducted to compare the effect of standard treatment (target LDL-C level: <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting the following inclusion criteria will be included in the study:
- •Patients giving voluntary written consent to participate in the study
- •Male or female patients 50 years of age or older (at informed consent)
- •Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
- •Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
- •Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)
- •Patients with two or more of the following risk factors
- •65 years of age or older
- •L/H ratio: ≥3.0 •HbA1c level: ≥8.0%
- •Left ventricular hypertrophy
- •First- or second-degree family history of MACE
- •Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (<60 mL/min/1.73 m2)
排除标准
- •Patients meeting the following criteria will be excluded from the study:
- •Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
- •Patients judged to have familial hypercholesterolemia
- •Patients with a serum triglyceride level of ≥400 mg/dL
- •Patients with a history of myocardial infarction
- •Patients with a history of coronary revascularization (PCI or CABG)
- •Patients with a history of treatment of unstable angina
- •Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
- •Heart failure patients
- •Patients with a history of hypersensitivity to statins
- •Patients with a history of drug-induced myopathy
- •Patients with poorly controlled arrhythmia
- •Patients with severe liver or kidney disease
- •Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
- •Patients who are or may be pregnant
- •Patients judged by the investigators to be ineligible for participation in the study for any other reason
研究组 & 干预措施
Active comparator: Standard Pravastatin Group
Active Comparator
干预措施: Pravastatin (Drug)
Intensive Rosuvastatin Group
Active Comparator
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
时间窗: At the end of the study or discontinuation up to 4 years
次要结局
- Prevention of individual MACE(At the end of the study (or discontinuation))
- Prevention of MACE(combination of each category)(At the end of the study (or discontinuation))
- Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)(At study completion up to 4 years)
- Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")(At the end of the study or discontinuation up to 4 years)
- Frequency and distribution of type of deaths during the study period(At the end of the study or discontinuation up to 4 years)
- Frequency and distribution of type of hospitalizations during the study period(At the end of the study or discontinuation up to 4 years)
- Frequency of other events (malignancy, dementia, need of nursing care)(At the end of the study or discontinuation up to 4 years)
- Frequency and type of adverse events(At the end of the study or discontinuation up to 4 years)
研究者
研究点 (309)
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