Therapeutic Window for Acute Therapy (P50)

急性治疗的治疗窗口 (P50)

• 批准号: 7762017
• 负责人: BRETT C MEYER
• 金额: $ 92.17万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-19 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7762017
• 关键词: Achievement; Acute; Address; Adult; Advisory Committees; Affect; Age; Animals; Area; Blood Pressure; Clinical; Clinical Trials; Control Groups; Effectiveness; Enrollment; Funding; Futility; Glucose; Grant; Heart Arrest; Hour; Human; Hypoxia; Injury; Intravenous; Ischemic Stroke; Modeling; Neonatal; Neuroprotective Agents; Outcome; Patients; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Physiological; Pneumonia; Protocols documentation; Randomized; Recruitment Activity; Regimen; Reperfusion Therapy; Research; Risk; Running; Safety; Saline; Sample Size; Site; Staging; Stroke; Symptoms; TNFRSF5 gene; Temperature; Therapeutic; Thrombolytic Therapy; Time; Tissues; acute stroke; arm; base; cohort; design; disability; efficacy trial; improved; indexing; meetings; natural hypothermia; phase 2 study; phase 3 study; preclinical study; programs; public health relevance; thrombolysis

DESCRIPTION (provided by applicant): The Intravascular Cooling in the Treatment of Stroke 2/3 trial (ICTuS 2/3) builds on the ongoing hypothermia research track of ICTuS-L, evolving from demonstration of the feasibility and safety of intravascular cooling in combination with thrombolysis to collaborative assessment, with Houston SPOTRIAS, of the efficacy of the endovascular induction of hypothermia in acute ischemic stroke patients presenting within the 3-hour window. We recruited an Advisory Committee, all of whom will serve as the study progresses, and revised the study to include hypothermia and normothermia arms in an efficacy design. ICTuS 2/3 is a definitive Phase 3 trial of 1600 patients who receive thrombolysis randomized to hypothermia vs normothermia. The trial will be run in 2 stages, a SPOTRIAS-funded Phase 2 study of 450 patients, followed by an R01 funded trial to complete the study. We plan that the 450 Phase 2 patients will be included in the 1600 sample size for phase 3. The purpose of Phase 2 under SPOTRIAS is to confirm that the revised protocol indeed eliminates the elevated risk of pneumonia seen in ICTuS-L; that intravenous 4¿C saline improves cooling effectiveness; and that recruitment can be sustained at 0.4 patients/site/month. In addition, a formal interim analysis for futility will occur after 400 patients. Funding for 450 patients under SPOTRIAS will allow us to continue site activity (enrollment) during the time of the interim analysis for futility. A go/no-go decision to proceed to Phase 3 will be made based on the achievement of the milestones and the interim analysis for futility. We hope to have a seamless transition from SPOTRIAS funding to R01 funding and end up with a pivotal 1600 patient Phase 3 study of endovascular hypothermia. PUBLIC HEALTH RELEVANCE: Stroke is the leading cause of adult disability in the US. Hypothermia is one of the most promising neuroprotective therapies identified in preclinical studies for stroke. ICTuS 2/3, will investigate the effect of hypothermia on clinical outcome and further delineate safety in combination with thrombolysis. Importantly, we will determine whether hypothermia can be deployed across a wide range of clinical trial sites.

描述（由适用提供）：中风2/3试验（ICTUS 2/3）的血管内冷却是基于持续的下温度研究轨迹的ICTUS-L研究，从表现出血管内冷却的可行性和安全性，与溶血率评估的可行性和安全性，以及与休斯顿·索斯特里亚（Houtton spotivia）的协作式，曾经是在休斯顿（Houtton soptricia）的效率上，既定性地有效性地有效性地指标。在3小时窗口内出现的患者。我们招募了一个咨询委员会，所有咨询委员会都将随着研究的进行，并修订了研究，以在有效的设计中包括体温过低和Normothermia Arms。 ICTUS 2/3是1600例接受溶栓与体温过低的患者的确定性3期试验。该试验将在两个阶段进行，这是一项由450名患者进行的现货资助的2期研究，然后进行了一项R01资助的试验以完成这项研究。我们计划在第3阶段的1600次样本量中包括450阶段2患者。第2阶段的目的是确认修订后的方案确实消除了ICTUS-L中肺炎的风险升高。静脉注射盐水盐水提高了冷却效果。并且该招聘可以在0.4名患者/现场/月的患者中维持。此外，在400例患者后，将进行融合的正式临时分析。在融合融合的临时分析期间，为450名患者提供450名患者的资金将使我们能够继续现场活动（入学率）。基于里程碑的成就和融合的临时分析，将进行第3阶段的决定。我们希望从现货资金到R01资金进行无缝过渡，最终得到1600个关键的患者3阶段3阶段的血管内体温过低研究。 公共卫生相关性：中风是美国成人残疾的主要原因。体温过低是中风研究中最有前途的神经保护疗法之一。 ICTUS 2/3将研究体温过低对临床结果的影响，并进一步描绘出与溶栓结合的安全性。重要的是，我们将确定是否可以在广泛的临床试验地点部署低温。