VITAMIN INTERVENTION FOR STROKE PREVENTION

预防中风的维生素干预

• 批准号: 2460620
• 负责人: JAMES F TOOLE
• 金额: $ 424.6万
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-15 至 2001-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2460620
• 关键词: cardiovascular disorder chemotherapy; chemoprevention; clinical research; clinical trials; folate; human subject; human therapy evaluation; myocardial infarction; pyridoxine; stroke; vitamin B12; vitamin therapy

This multicenter, double-blind, randomized, controlled clinical trial has been designed to determine whether the addition of a multivitamin with high dose folic acid, pyridoxine, and cyanocobalamin to best medical management and risk factor modification reduces recurrent cerebral infarction (primary endpoint) and myocardial infarction (secondary endpoint) in patients with a first nondisabling cerebral infarction (NDCI) who have elevated homocyst(e)ine levels. The fundamental eligibility criteria are the occurrence of a first-ever NDCI within 30 days prior to randomization and homoeyst(e)ine >10.5 nmo1/m1 at screening visit. Patients will be randomly assigned to receive a daily multivitamin containing, in addition to standard multivitamins, a high or low dose of folic acid, pyridoxine, and cyanocobalamin. Randomized patients will also receive a methionine loading test. All patients will receive best management for risk factor reduction. The study is designed to recruit 3600 patients (1800 in each group) over a 2-year-period for 80% power for detection of a 30% treatment effect. Follow-up continues until recurrent stroke, death, or a maximum of 2 years. Analysis will be in terms of original randomization (intent-to-treat analysis) using the log-rank test of difference in survival-without-endpoint curves. The incidence of second stroke in patients who have had a first stroke is between 7-10% per year. Myocardial infarction adds a major increment to morbidity and mortality. Because homocyst(e)ine may be a major contributor to the etiology of atherothrombotic disease and is an independent risk factor for these complications, its reduction by appropriate intervention with vitamin supplements could reduce the impact of recurrent stroke, myocardial infarction and vascular death. This inexpensive intervention has the potential for being added to other risk factor reduction customary therapy. It may substitute for more dangerous and complicated managements which include warfarin or more expensive therapies such as ticlopidine which are commonly advocated for secondary prevention of stroke, particularly in patients who are aspirin resistant. The long term effects and putative toxicity to vitamin supplementation will be delineate.

这项多中心、双盲、随机、对照的临床试验 旨在确定添加具有多种维生素的 大剂量叶酸、吡哆醇和氰钴胺是最好的药物 管理和危险因素调整可减少脑部复发 心肌梗塞(主要终点)和心肌梗死(继发性 首发非致残性脑梗塞患者中的 (NDCI)同型半胱氨酸水平升高。最基本的 资格标准是在30年内首次出现NDCI 随机化前几天和筛查时的同型(E)和同型(E)；10.5nmo1/m1 参观。患者将被随机分配每天接受一种复合维生素 除了标准的复合维生素外，还含有高剂量或低剂量的 叶酸、吡哆醇和氰钴胺。随机分组的患者也将 接受蛋氨酸负荷测试。所有患者都将得到最好的 降低风险因素的管理。这项研究旨在招募 3600名患者(每组1800名)在两年内获得80%的治疗功率 检测到30%的治疗效果。继续跟踪，直到复发 中风、死亡或最多2年。分析将在以下方面进行 使用对数等级检验的原始随机化(意向处理分析) 无终点生存曲线的差异。 首次卒中患者二次卒中的发生率 每年在7%到10%之间。心肌梗死增加了一个主要的增量 致残率和死亡率。因为同型半胱氨酸可能是主要的 动脉粥样硬化性血栓性疾病病因学的贡献者 这些并发症的独立危险因素，其减少 适当的维生素补充剂干预可以减少这种影响。 再发中风、心肌梗死和血管死亡。这 廉价的干预措施有可能增加其他风险。 因子减少法常规治疗。它可能会取代更危险的东西 以及复杂的管理，包括华法林或更昂贵的 通常提倡的继发性疾病的治疗方法，如噻氯匹定 预防中风，特别是对阿司匹林抵抗的患者。 维生素补充剂的长期效应和潜在毒性 将会被描绘出来。