Field Administration of Stroke Therapy-Magnesium Trial (FAST-MAG)

中风治疗现场管理-镁试验 (FAST-MAG)

• 批准号: 8442766
• 负责人: JEFFREY L SAVER
• 金额: $ 213.31万
• 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 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8442766
• 关键词: Activities of Daily Living; Adult; Alteplase; Ambulances; American; Award; Brain; Cause of Death; Cerebral hemisphere hemorrhage; Clinical Trials; Disabled Persons; Dose; Double-Blind Method; Enrollment; Hour; Individual; Intention; Intravenous; Ischemic Stroke; Magnesium; Magnesium Sulfate; Maintenance; Measures; Neurologic Deficit; Neuroprotective Agents; Outcome; Paramedical Personnel; Patients; Phase; Phase III Clinical Trials; Placebos; Protective Agents; Quality of life; Randomized; Stroke; Subgroup; Symptoms; Testing; Time; Treatment Efficacy; United States; United States National Institutes of Health; acute stroke; arm; disability; functional outcomes; handicapping condition; improved; indexing; mortality; post stroke; public health relevance; stroke therapy

DESCRIPTION (provided by applicant): Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year in the US, 795,000 Americans suffer a symptomatic 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. 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 1700 patients will be enrolled, 850 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 poststroke. 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795,000名美国人遭受症状中的中风。 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。研究代理人将在所有入学的个体的中风发作后两个小时内以及大约一半的入学个体发作后的一小时内开始。总共将招募1700名患者，每个治疗组中有850名患者。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的分布分布的差异，并在中风后3个月评估。 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。

项目成果

Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.

• DOI: 10.1161/strokeaha.115.011687
• 发表时间: 2016-01
• 期刊: Stroke
• 影响因子: 8.3
• 作者: Kim DH;Saver JL;Starkman S;Liebeskind DS;Ali LK;Restrepo L;Kim-Tenser M;Valdes-Sueiras M;Eckstein M;Pratt F;Stratton S;Hamilton S;Conwit R;Sanossian N;Field Administration of Stroke Therapy–Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators
• 通讯作者: Field Administration of Stroke Therapy–Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators

Improving the reliability of stroke disability grading in clinical trials and clinical practice: the Rankin Focused Assessment (RFA).

• DOI: 10.1161/strokeaha.109.571364
• 发表时间: 2010-05
• 期刊: Stroke
• 影响因子: 8.3
• 作者: Saver JL;Filip B;Hamilton S;Yanes A;Craig S;Cho M;Conwit R;Starkman S;FAST-MAG Investigators and Coordinators
• 通讯作者: FAST-MAG Investigators and Coordinators

Relationship between neurologic deficit severity and final functional outcome shifts and strengthens during first hours after onset.

• DOI: 10.1161/strokeaha.111.636928
• 发表时间: 2012-06
• 期刊: Stroke
• 影响因子: 8.3
• 作者: Saver JL;Altman H
• 通讯作者: Altman H

Prehospital use of magnesium sulfate as neuroprotection in acute stroke.

• DOI: 10.1056/nejmoa1408827
• 发表时间: 2015-02-05
• 期刊: The New England journal of medicine
• 作者: Saver JL;Starkman S;Eckstein M;Stratton SJ;Pratt FD;Hamilton S;Conwit R;Liebeskind DS;Sung G;Kramer I;Moreau G;Goldweber R;Sanossian N;FAST-MAG Investigators and Coordinators
• 通讯作者: FAST-MAG Investigators and Coordinators

Intercontinental elicitation of informed consent for enrollment in stroke research.

洲际征求中风研究入组知情同意书。

• DOI: 10.1159/000319609
• 发表时间: 2010
• 期刊: Cerebrovascular diseases (Basel, Switzerland)
• 作者: Sanossian,Nerses;Starkman,Sidney;Eckstein,Mark;Stratton,Samuel;Pratt,Frank;Conwit,Robin;Saver,JeffreyL;FAST-MAGTrialInvestigators
• 通讯作者: FAST-MAGTrialInvestigators