Field Administration of Stroke Therapy - Magnesium Trial

中风治疗现场管理 - 镁试验

• 批准号: 7238731
• 负责人: JEFFREY L SAVER
• 金额: $ 376万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7238731
• 关键词: Activities of Daily Living; Adult; Alteplase; Ambulances; American; Cause of Death; Cerebral hemisphere hemorrhage; Daily; Disabled Persons; Dose; Double-Blind Method; End Point; Enrollment; Hour; Individual; Intention; Intravenous; Ischemic Stroke; Life; Magnesium; Magnesium Sulfate; Maintenance; Measures; Neurologic Deficit; Neuroprotective Agents; Numbers; Outcome; Paramedical Personnel; Patients; Phase; Phase III Clinical Trials; Placebos; Quality of life; Randomized; Score; Stroke; Subgroup; Symptoms; Testing; Time; Tissues; Treatment Efficacy; United States; United States National Institutes of Health; Upper arm; acute stroke; disability; functional outcomes; handicapping condition; improved; indexing; mortality; post stroke; programs; stroke therapy

DESCRIPTION (provided by the applicant): Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year in the U.S., 750,000 Americans suffer a symptomatic stroke, and over 11 million suffer an asymptomatic stroke. The central aim of this proposal is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an efficacious and safe treatment for acute stroke. The proposal is a multicenter, randomized, double-blind, Phase 3 clinical trial, using intention to treat analysis, of magnesium sulfate versus placebo among ambulance-transported patients with acute stroke. A study agent will be initiated within two hours of stroke onset in all enrolled individuals, and within one hour of onset in approximately one-half of enrolled individuals. A total of 1,270 patients will be enrolled, 635 in each treatment arm. The dose of magnesium sulfate employed will be 4 gram IV loading dose over 15 minutes, followed by 16 gram IV maintenance dose over 24 hours. The primary study hypothesis is that treatment with magnesium sulfate improves the long-term functional outcome of hyperacute stroke patients. The primary study endpoint will be the difference in distribution of scores between magnesium sulfate and placebo groups on the modified Rankin Scale measure of global handicap, assessed 3 months post-stroke. Secondary analyses will analyze treatment efficacy on endpoints indexing neurologic deficit, activities of daily living, global outcome, and quality-of-life, and in prespecified patient subgroups, including patients with ischemic stroke, ischemic stroke co-treated with tissue plasminogen activator, ischemic stroke not co-treated with tissue plasminogen activator, intracerebral hemorrhage, patients treated within 15-60 minutes of symptom onset, and within 61-120 minutes of symptom onset. Successful conduct of the trial will serve as a pivotal test of the promising neuroprotective agent magnesium sulfate in acute stroke, and will also demonstrate for the first time that field enrollment and treatment of acute stroke patients is a practical and feasible strategy for Phase 3 stroke trials, permitting enrollment of greater numbers of patients in hyperacute time windows.

描述（由申请人提供）：中风是美国第三大死亡原因，是美国成人残疾的主要原因。 每年在美国，有750,000名美国人遭受症状的中风，超过1100万人遭受无症状的中风。 该提案的核心目的是证明该领域神经保护剂硫酸镁的启动是对急性中风的有效且安全的治疗。 该提案是一项多中心，随机，双盲，第3阶段临床试验，使用硫酸镁与安慰剂在急性中风的患者中对硫酸镁与安慰剂的意图。 在所有入学的个体中，在大约一半的入学人群中，将在中风发作后的两个小时内启动研究代理。 总共将招募1,270名患者，每个治疗组中有635例。 硫酸镁的剂量将在15分钟内为4克IV剂量，然后在24小时内进行16克IV维持剂量。 主要研究假设是，用硫酸镁治疗改善了超急性中风患者的长期功能结果。 主要的研究终点将是硫酸镁和安慰剂组之间在修改后的兰金尺度量度测量全球障碍量表上分数分布的差异，并评估了3个月。 次要分析将分析端点上的治疗疗效，以索引神经系统缺陷，日常生活，全球结果和生活质量的活动以及预先指定的患者亚组，包括与组织基因基因激活剂，缺血性静脉基因激活者，缺血性的缺血性中风的缺血性中风，与无脑静脉内的血管生基因促进性等化剂的血液含量，该血液含量为等级的血液含量，症状发作15-60分钟，在症状发作的61-120分钟内。 该试验的成功进行将作为对急性中风中有希望的神经保护剂硫酸镁的关键检验，并且还将首次证明急性中风患者的现场入学和治疗是3期冲程试验的实用且可行的策略，从而使超急性时间窗口中有更多的患者招募了更多的患者。