CSP #363 - The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,531
- 试验地点
- 1
- 主要终点
- incidence of nonfatal myocardial infarction or death from coronary heart disease
研究概览
简要总结
This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of 140 mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal myocardial infarction(MI) or death from coronary causes. The median follow-up was 5.1 years. There was a risk reduction of 22% in the primary outcome (p=.0006) and 24% risk reduction in the combined endpoint of stroke, MI, and CHD death. The rate of events was reduced by raising HDL-C and lowering triglycerides without lowering LDL-C (N Engl J Med 1999;341:410-418).
详细描述
Primary Hypothesis:
To determine if drug treatment aimed at raising HDL-cholesterol and lowering triglycerides will reduce the rate of heart attack and death in veterans with coronary heart disease (CHD) and a specific lipid profile characterized by normal levels of LDL-cholesterol and low levels of HDL-cholesterol.
Secondary Hypotheses:
To determine the effect of treatment on total mortality, unstable angina, CABG, PTCA, strokes and PVD, and to determine whether there is an association between changes in plasma lipid levels and outcomes.
Primary Outcomes:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 73 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •male gender
- •age 73 or younger
- •presence of CHD
- •HDL-C le 40 mg/dl
- •LDL-C le 140 mg/dl
- •triglycerides le 300 mg/dl
排除标准
- •Exclusion criteria:
- •significant medical illness
- •alcohol or substance abuse
- •evidence of cholecystitis or cholelithiasis
- •ejection fraction of lt 35%
- •current use of steroids, estrogens, immunosuppressive agents, oral coagulants, or lipid modifying drug.
- •allergic to gemfibrozil or fibric acid
- •refused informed consent
研究组 & 干预措施
Placebo
Matching placebo tablets taken once per day
干预措施: Placebo (Other)
Gemfibrozil
1200 mg slow-release gemfibrozil (Lopid-SR) once per day
干预措施: gemfibrozil (Drug)
结局指标
主要结局
incidence of nonfatal myocardial infarction or death from coronary heart disease
时间窗: 5 years
次要结局
未报告次要终点