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 高剂量叶酸、吡哆醇和氰钴胺可达到最佳医疗效果 管理和危险因素修正可减少复发性脑病 梗塞（主要终点）和心肌梗塞（次要终点） 首次非致残性脑梗塞患者的终点） (NDCI) 同型半胱氨酸水平升高的人。基本的 资格标准是在 30 年内首次出现 NDCI 随机分组前天，筛选时同型半胱氨酸 >10.5 nmo1/m1 访问。患者将被随机分配接受每日多种维生素治疗 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。随机分组的患者还将 接受蛋氨酸负荷测试。所有患者都将得到最好的治疗 减少风险因素的管理。该研究旨在招募 2 年期间 3600 名患者（每组 1800 名）的 80% 功效 检测30%的治疗效果。随访持续至复发 中风、死亡或最长 2 年。分析将根据 使用对数秩检验进行原始随机化（意向治疗分析） 无终点生存曲线的差异。 第一次中风患者中第二次中风的发生率 每年在 7-10% 之间。心肌梗塞增加了一个主要增量 发病率和死亡率。因为同型半胱氨酸可能是主要的 动脉粥样硬化血栓性疾病的病因学的贡献者，并且是 这些并发症的独立危险因素，其减少 补充维生素进行适当干预可以减少影响 复发性中风、心肌梗塞和血管性死亡。这 廉价的干预措施有可能增加其他风险 因子减少常规疗法。它可能会替代更危险的 以及复杂的管理，其中包括华法林或更昂贵的药物 通常提倡用于继发性治疗的疗法，例如噻氯匹定 预防中风，特别是对阿司匹林耐药的患者。 维生素补充剂的长期影响和假定毒性 将会被划定。