VITAMIN INTERVENTION FOR STROKE PREVENTION

预防中风的维生素干预

• 批准号: 2892007
• 负责人: JAMES F TOOLE
• 金额: $ 482.99万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 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/2892007
• 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、对照临床试验 旨在确定是否添加多种维生素与 高剂量叶酸，吡哆醇，维生素B12，最好的医疗 管理和风险因素的修改减少了复发性脑 梗死（主要终点）和心肌梗死（次要终点 终点）的非致残性脑梗死患者 （NDCI）具有升高的同型半胱氨酸水平。根本 资格标准是在30年内首次发生NDCI 随机化前10天，筛选时同型半胱氨酸>10.5 nmo 1/m1 访问患者将被随机分配接受每日多种维生素 除了标准的多种维生素外，还含有高剂量或低剂量的 叶酸吡哆醇和氰钴胺随机化患者还将 接受甲硫氨酸负荷试验。所有患者将接受最好的 降低风险因素的管理。这项研究旨在招募 2年期间3600例患者（每组1800例），80%把握度 检测到30%的治疗效果。随访持续至复发 中风、死亡或最多2年。分析将根据 使用对数秩检验的初始随机化（意向治疗分析） 无终点生存曲线的差异。 首次卒中患者再次卒中的发生率 每年在7-10%之间。心肌梗死增加了 发病率和死亡率。因为同型半胱氨酸可能是 动脉粥样硬化血栓形成疾病的病因，是一个 这些并发症的独立风险因素，其减少， 适当的维生素补充剂干预可以减少影响， 复发性中风、心肌梗死和血管性死亡。这 廉价的干预有可能增加其他风险 减少因子的常规疗法。它可以取代更危险的 和复杂的管理，其中包括华法林或更昂贵的 噻氯匹定等治疗，通常主张用于继发性 预防中风，特别是阿司匹林抵抗的患者。 维生素补充剂的长期影响和推定毒性 将被描绘出来。