Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,750
- 试验地点
- 2
- 主要终点
- The primary end point was a composite of
研究概览
简要总结
The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease
详细描述
Observational studies have demonstrated that elevated levels of plasma total homocysteine is a risk factor for cardiovascular disease. The purpose of this trial is to evaluate the efficacy of homocysteine lowering treatment with B vitamins for secondary prevention in patients who have experienced an acute myocardial infarction.
This controlled, double-blind, multi-centre trial will include 3750 men and women aged 30-85 who have experienced an acute myocardial infarction within 7 days prior to randomization. Participants will be randomized, in a two-by-two factorial design, to receive one of the following four treatments: A, folic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg per day; B, folic acid 0.8 mg plus vitamin B12 0.4 mg per day; C, vitamin B6 40 mg per day; D, placebo.
The primary end point during 3.5 years of follow-up is a composite of recurrent myocardial infarction and stroke and sudden death attributed to coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction within 7 days prior to randomization
- •Men and women aged 30-85 years
- •Written informed consent
排除标准
- •Coexisting disease that shortens expected survival to less than 4 years
- •Ongoing treatment with B vitamins
- •Expected poor compliance
结局指标
主要结局
The primary end point was a composite of
nonfatal stroke,
fatal myocardial infarction,
nonfatal myocardial infarction,
fatal stroke, and
sudden death attributed to coronary heart disease.
次要结局
- Transitoric ischemic attack
- Individual components of the primary end point, i.e.
- Nonfatal myocardial infarction
- Surgery for abdominal aortic aneurysm
- Plasma homocysteine levels
- Nonfatal stroke
- Fatal stroke
- Unstable angina pectoris requiring hospitalization
- Cancer
- Fatal myocardial infarction
- Percutaneous coronary revascularization
- Coronary-artery bypass grafting
- Pulmonary embolus
- In addition the following secondary outcomes:
- Death from any cause
- Plasma levels of B vitamins