NCT00327691已完成4 期
The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8,600
- 试验地点
- 314
- 主要终点
- The primary outcome is the time to occurrence of a major
研究概览
简要总结
The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 35-75 who have evident CHD
排除标准
- •Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia
结局指标
主要结局
The primary outcome is the time to occurrence of a major
cardiovascular event, defined as the composite outcome of the
following clinical endpoints
CHD death
Non-fatal/Non-procedure related MI
Resuscitated cardiac arrest or fatal/non-fatal stroke
次要结局
- The occurrence of the following clinical events
- Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)
- any coronary event (major coronary event or CABG
- PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)
- cerebrovascular event (fatal or non fatal stroke, TIA)
- peripheral vascular disease; hospitalization with primary diagnosis' of CHF
- any cardiovascular event (any of the above); and all-cause mortality.
研究者
研究点 (314)
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