STROKE PREVENTION IN ATRIAL FIBRILLATION

房颤中的中风预防

• 批准号: 3408560
• 负责人: DAVID G SHERMAN
• 金额: $ 193.44万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-01-01 至 1993-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3408560
• 关键词: aging; aspirin; atrial fibrillation; cardiovascular disorder chemotherapy; cardiovascular disorder epidemiology; cardiovascular disorder prevention; cerebral ischemia /hypoxia; chemoprevention; clinical trials; dosage; drug adverse effect; echocardiography; human old age (65+); human subject; human therapy evaluation; longitudinal human study; stroke; ultrasound blood flow measurement; warfarin

Nonrheumatic atrial fibrillation (AF) occurs in 1.5 million Americans and carries a fivefold increased risk of stroke - some 75,000 strokes yearly. In November 1989, the first phase of the SPAF Study was terminated early due to unequivocal evidence that both aspirin and warfarin were superior to placebo for stroke prevention (p<.02, 49-81% reduction). Data were insufficient to determine the relative value of aspirin vs. warfarin. Major objectives of the multicenter, randomized, ongoing SPAF Study are to: 1. Compare the efficacy/safety of warfarin vs. aspirin for stroke prevention in AF pts. a. over a 2-4 yr follow-up period to assure sustained effects. b. assessing stroke severity/functional outcome vs. treatments. 2. Identify subgroups who might differentially respond to aspirin vs. warfarin, particularly age, sex and presence of carotid artery disease. 3. Organize a collaborative meta-analysis of recent randomized antithrombotic trials. Design: SPAF is a randomized treatment-efficacy trial ongoing at 15 clinical sites testing aspirin 325mg/day vs. warfarin (prothrombin time range 1.3-1.8 control) given nonblindedly. Primary events (ischemic stroke, systemic embolism) are assessed by a blinded Events Committee. The 1050 sample size allows independent determination of efficacy in pts under age 76 (n=675) and pts over age 75 (n=375). Power to detect clinically important differences in aspirin vs. warfarin is >.8 in each age group(alpha = .05, two-sided] By June 1990, 810 pts have been entered. Entry of pts over age 75 continues until June 1991 with follow-up of all pts until December 1992. Relevance: Recent randomized trials show that warfarin anticoagulation importantly reduces the stroke risk in AF pts. SPAF proved that aspirin is also effective, but that this effect is not uniform in all subpopulations. Determination of which pts should receive aspirin vs. warfarin is a critical clinical issue, affecting millions of people with AF. SPAF is the only clinical trial likely to yield an answer in the forseeable future.

150 万美国人患有非风湿性心房颤动 (AF) 中风的风险增加五倍——每年约 75,000 起中风。 1989年11月，SPAF第一阶段研究提前终止 由于明确的证据表明阿司匹林和华法林均优于 与安慰剂相比，用于预防中风（p<.02，减少 49-81%）。 数据为 不足以确定阿司匹林与华法林的相对价值。 正在进行的多中心、随机、SPAF 研究的主要目标是 到： 1. 比较华法林与阿司匹林治疗中风的疗效/安全性 AF 点的预防。 一个。 2-4年的随访期以确保持续的效果。 b.评估中风严重程度/功能结果与治疗。 2. 确定对阿司匹林可能有不同反应的亚组 与华法林相比，特别是年龄、性别和颈动脉的存在 动脉疾病。 3. 组织最近随机的协作荟萃分析 抗血栓试验。 设计：SPAF 是一项随机治疗效果试验，于 15 日进行 临床站点测试阿司匹林 325 毫克/天与华法林（凝血酶原时间 范围1.3-1.8控制）非盲给出。 主要事件（缺血性 中风、全身性栓塞）由盲法事件委员会进行评估。 1050 个样本量允许独立确定患者的疗效 76 岁以下 (n=675) 和 75 岁以上 (n=375)。 检测功率 阿司匹林与华法林的临床重要差异均>.8 年龄组（alpha = .05，两侧） 到 1990 年 6 月，已有 810 分 进入。 75 岁以上的患者继续进入 1991 年 6 月 对所有患者进行随访直至 1992 年 12 月。 相关性：最近的随机试验表明华法林具有抗凝作用 重要的是降低 AF 患者中风的风险。 SPAF证明阿司匹林 也是有效的，但是这种效果并不统一 亚人群。 确定哪些患者应该接受阿司匹林治疗，哪些患者应该接受阿司匹林治疗？ 华法林是一个关键的临床问题，影响着数百万人 AF。 SPAF 是唯一可能给出答案的临床试验 可预见的未来。