WARFARIN VS ASPIRIN FOR INTRACRANIAL ARTERIAL STENOSIS

华法林与阿司匹林治疗颅内动脉狭窄

• 批准号: 6529215
• 负责人: MARC IVOR CHIMOWITZ
• 金额: $ 309.01万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-25 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6529215
• 关键词: artery stenosis; aspirin; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; cerebrovascular disorders; clinical research; clinical trials; human subject; human therapy evaluation; stroke; warfarin

Background and Relevance. Atherosclerotic stenosis of the major intracranial arteries causes 40,000 strokes per year in the USA, costing the country at least 600,000,000 dollars annually. There have been no prospective trials evaluating optimal medical therapy for this disease. The main objective of this clinical trial is to compare warfarin (INR 2-3) with aspirin (1300 mg/day) for preventing stroke (ischemic and hemorrhagic) and vascular death in patients with symptomatic stenosis of a major intracranial artery. Study Design. Prospective, randomized, double-blind, multi-center trial. The sample size required will be 403 patients per group (based on stroke and vascular death rates of 33 percent/3 years in the aspirin group vs 22 percent/3 years in the warfarin group, an alpha of 0.05, beta of 0.80, a 24 percent withdrawal of therapy rate, and a 1 percent drop out rate). Conduct of Trial. Patients with transient ischemic attack (TIA) or stroke caused by angiographically proven stenosis (greater than or equal to 50 percent) of a major intracranial artery will be randomized to warfarin or aspirin. The dose of warfarin will be adjusted to maintain the INR between 2-3 based on monthly blood tests. Patients will be contacted monthly by phone and examined every four months (mean follow-up of 3 years) to determine whether any endpoints have occurred. The primary analysis will compare the rates of stroke (ischemic and hemorrhagic) and vascular death in the two treatment groups. Secondary analyses will compare the two treatment groups with respect to rates of i) all vascular deaths and disabling stroke, ii) all stroke (ischemic and hemorrhagic), iii) fatal and nonfatal ischemic stroke, iv) all ischemic stroke, myocardial infarction and vascular death, v) all major systemic and any intracranial hemorrhage, vi) all ischemic stroke in the territory of the stenotic intracranial artery. Conclusion. This study will 1) define optimal medical therapy for patients with symptomatic intracranial arterial stenosis, and 2) identify patients whose rate of ischemic stroke in the territory of the stenotic intracranial artery on best medical therapy is sufficiently high (i.e., greater than or equal to 6 percent per year) to justify a subsequent trial comparing intracranial angioplasty with best medical therapy in these patients.

背景和相关性。动脉粥样硬化性大动脉狭窄 在美国，颅内动脉导致每年40，000例中风， 该国每年至少花费6亿美元。 没有发生 前瞻性试验评估这种疾病的最佳药物治疗。 这项临床试验的主要目的是比较华法林（INR 2-3)阿司匹林（1300毫克/天）预防中风（缺血性和 出血性）和血管性死亡 颅内主要动脉的。 研究设计.前瞻性、随机、 双盲多中心试验。 所需样本量为403 每组患者（基于卒中和血管性死亡率33 阿司匹林组为22%/3年， 华法林组，α为0.05，β为0.80，停药率为24 治疗率和1%的辍学率）。 审判的进行。 短暂性脑缺血发作（TIA）或卒中患者， 血管造影证实的狭窄（大于或等于50%） 将被随机分配至华法林组或 阿司匹林 将调整华法林剂量以维持INR 根据每月的血液检查，2-3之间。 将联系患者 每月通过电话进行一次，每四个月进行一次检查（平均随访3次 以确定是否发生了任何终点。 主 分析将比较中风（缺血性和出血性）的发生率， 两个治疗组的血管性死亡。次要分析将 比较两个治疗组i）所有 血管性死亡和致残性卒中，ii）所有卒中（缺血性和 出血性），iii）致死性和非致死性缺血性卒中，iv）所有缺血性 中风、心肌梗死和血管性死亡，v）所有主要的全身性 和任何颅内出血，vi）所有缺血性中风， 狭窄的颅内动脉的区域。 结论本研究 将1）为有症状的患者定义最佳药物治疗 颅内动脉狭窄，和2）确定患者的比率， 缺血性中风在狭窄的颅内动脉的领土上 最好的医学治疗是足够高的（即，大于或等于 到每年6%），以证明随后的试验比较 颅内血管成形术与最佳药物治疗。