Phase IIB Study of TNK in Acute Stroke (TNK-S2B-STAT)

TNK 治疗急性中风的 IIB 期研究 (TNK-S2B-STAT)

• 批准号: 7796985
• 负责人: JOHN L THOMPSON
• 金额: $ 14.12万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-19 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7796985
• 关键词: Acute; Alteplase; Clinical; Clinical Trials; Controlled Clinical Trials; Data; Dose; Ensure; Fibrinolytic Agents; Funding; Futility; Goals; Hemorrhage; Hour; Ischemic Stroke; Neurologic; Operative Surgical Procedures; Outcome; Patients; Phase; Phase III Clinical Trials; Principal Investigator; Procedures; Randomized; Randomized Controlled Trials; Research; Safety; Symptoms; Tenecteplase; Testing; Time; acute stroke; data management; design; follow-up; innovation; meetings; patient safety; trial comparing

TNK-S2B STAT and TNK-S2B CLIN are separate but highly coordinated units which together propose a large, multi-center, randomized controlled trial comparing TNK to rt-PA in patients with acute ischemic stroke treated within 3 hours of onset. The goals of TNK-S2B STAT are: 1) to provide a statistical design which establishes whether, compared to rt-PA, TNK shows promise in reducing poor outcomes following acute ischemic stroke, while minimizing follow-up time and the number of patients required. 2) to conduct, efficiently integrate, and be responsible for all TNK-S2B data management operations. 3) to transmit to the Clinical Coordinating Center (CCC) in a timely fashion all of the data which the principal investigator of TNK-S2B needs to meet his responsibilities in terms of ensuring patient safety and directing all clinical operations. The statistical analysis plan incorporates several innovative features: 1) A sequential selection procedure identifies one of two doses of TNK (0.1 or 0.4 mg/kg) as superior for Major Neurological Improvement at 24 hours. 2) An initial randomized comparison to rt-PA assesses the selected TNK dose for promise or futility. The outcome is the modified Rankin scale at 3 months. 3) If TNK is promising rather than futile, a phase III trial will compare TNK with rt-PA, again with the modified Rankin scale at 3 months as outcome. 3)For efficiency, the 200 patients included in the initial TNK/rt-PA comparison will be included in the phase III trial (overall n = 1908 patients) if it proceeds.

TNK- s2b STAT和TNK- s2b CLIN是独立但高度协调的单元，它们共同提出了一项大型、多中心、随机对照试验，比较TNK和rt-PA在发病3小时内治疗的急性缺血性卒中患者中的疗效。TNK- s2b STAT的目标是：1)提供一个统计设计，确定与rt-PA相比，TNK是否有希望减少急性缺血性卒中后的不良预后，同时最大限度地减少随访时间和所需的患者数量。2)开展、高效整合并负责秋明- s2b的所有数据管理工作。3)及时向临床协调中心（CCC）传送TNK-S2B项目首席研究员履行其确保患者安全和指导所有临床操作职责所需的所有数据。统计分析计划包含几个创新功能：