Statistical and Data Coordinating Center for the ATACH - 2

ATACH 统计和数据协调中心 - 2

基本信息

批准号：
8243644
负责人：
Yuko Y Palesch
金额：
$ 20万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-04-15 至 2015-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8243644
关键词：
Acute Amendment Antihypertensive Agents Applications Grants Bioinformatics Biometry Blood Pressure Calendar Case Report Form Case Series Cerebral hemisphere hemorrhage Certification Cessation of life Clinical Clinical Data Clinical Investigator Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Code Collaborations Common Data Element Computers Data Data Base Management Data Collection Data Coordinating Center Data Quality Databases Death Rate Department of Defense Development Educational Curriculum Eligibility Determination Enrollment Ensure Epidemiology Feedback Funding Generations Glasgow Coma Scale Goals Good Clinical Practice Growth Guidelines Health Health Insurance Portability and Accountability Act Hematoma Hour Human Resources Hypertension Informed Consent Infusion procedures Institutional Review Boards Internet Intravenous Laboratories Language Licensing Logic Maintenance Manuals Measures Mediating Medical Medical Research Minnesota Modeling Monitor National Institute of Neurological Disorders and Stroke Nicardipine Odds Ratio Online Systems Outcome Patients Phase III Clinical Trials Principal Investigator Procedures Public Health Publications Quality of life Randomized Randomized Controlled Trials Recruitment Activity Regimen Regulation Relative (related person)Relative Risks Reporting Research Personnel Risk Role Safety Schedule Secure Serious Adverse Event Site South Carolina Specific qualifier value Statistical Methods Stroke Structure Study Subject Supratentorial Symptoms System Therapeutic Time Traumatic Brain Injury United States Food and Drug Administration United States National Institutes of Health Universities Work acute stroke attenuation base clinical research site computerized data processing data management design disability experience follow-up implementation trial innovation intraventricular hemorrhage meetings neuroimaging organizational structure patient population payment pilot trial primary outcome public health relevance standard care stroke therapy tomography tool tool development web site web-enabled

项目摘要

DESCRIPTION (provided by applicant): In collaboration with the University of Minnesota (UMN), we propose to conduct a five-year multicenter, randomized Phase III trial to determine the efficacy of early, intensive antihypertensive treatment with nicardipine for acute hypertension in subjects with supratentorial intracerebral hemorrhage (ICH). The primary hypothesis of this trial is that the group treated with intensive blood pressure reduction (SBP of <140 mm Hg) using intravenous nicardipine infusion for 24 hours reduces the proportion of death and disability at 3 months by 10% or greater compared with the group treated with the standard blood pressure reduction (SBP of <180 mm Hg) among patients with ICH treated within 3 hours of symptom onset. The underlying mechanism for this expected beneficial effect of intensive treatment is mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 38% of patients with acute ICH. The trial will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria. The primary outcome is the proportion of death and disability at 3 months defined by modified Rankin scale (mRS) score of 4 to 6. The specific aims of the ATACH II Trial are to: (1) Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 3 hours of symptom onset; (2) Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months; (3) Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of >33%); and (4) Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related SAEs within 72 hours. The accompanying grant application of the UMN describes the details of the clinical background and rationale, eligibility criteria, treatment and follow-up procedures, and the organizational structure of the ATACH II Trial. The Data Coordination Unit (DCU) in the Department of Biostatistics, Bioinformatics an Epidemiology (DB2E) at the Medical University of South Carolina (MUSC) will serve as the statistical and data coordination center for the ATACH II Trial. In this application, we describe the aims and the expertise/qualifications of the DCU, its role in the ATACH II Trial, and the details of data processing and management, and the statistical design, issues and analysis plan. PUBLIC HEALTH RELEVANCE: The proposed ATACH II Trial is a five-year multicenter randomized Phase III trial to determine the efficacy of early, intensive antihypertensive treatment for acute hypertension in subjects with supratentorial intracerebral hemorrhage (ICH). The primary hypothesis of this large, streamlined, and focused trial is that the group treated with intensive systolic blood pressure (SBP) reduction (<140 mm Hg) using intravenous nicardipine infusion for 24 hours reduces the proportion of death and disability (defined as the modified Rankin Scale score of 4-6) at 3 months from randomization by 10% or greater compared with the group treated with the standard SBP reduction (<180 mm Hg) among patients with ICH treated within 3 hours of symptom onset.

描述（由申请人提供）：我们建议与明尼苏达大学 (UMN) 合作，进行一项为期五年的多中心、随机 III 期试验，以确定尼卡地平早期强化抗高血压治疗对患有以下疾病的受试者的急性高血压的疗效：幕上脑出血（ICH）。该试验的主要假设是，使用尼卡地平静脉输注 24 小时强化降压（SBP <140 mm Hg）治疗组与对照组相比，3 个月时的死亡和残疾比例降低了 10% 或更多ICH 患者在症状出现 3 小时内接受标准降压治疗（SBP <180 mm Hg）。强化治疗的这种预期有益效果的潜在机制是通过降低约 38% 的急性 ICH 患者观察到的血肿扩张速度和程度来介导的。该试验将招募最多 1,280 名符合资格标准的 ICH 受试者。主要结局是 3 个月时死亡和残疾的比例，由改良 Rankin 量表 (mRS) 评分为 4 至 6 分定义。 ATACH II 试验的具体目的是： (1) 最终确定强化治疗的治疗益处在症状出现 3 小时内接受治疗的 ICH 受试者中，与标准治疗相比，3 个月时死亡和残疾的比例 (mRS 4-6)； (2)评估强化治疗相对于标准治疗在受试者3个月时的生活质量方面的治疗益处；（3）评估强化治疗相对于标准治疗的血肿扩大比例（定义为血肿量较基线增加>33%）的治疗效益； (4) 根据72小时内出现治疗相关SAE的受试者比例来评估强化治疗相对于标准治疗的安全性。随附的 UMN 拨款申请描述了 ATACH II 试验的临床背景和基本原理、资格标准、治疗和随访程序以及组织结构的详细信息。南卡罗来纳医科大学 (MUSC) 生物统计、生物信息学和流行病学 (DB2E) 系的数据协调单位 (DCU) 将作为 ATACH II 试验的统计和数据协调中心。在此应用程序中，我们描述了 DCU 的目标和专业知识/资格、其在 ATACH II 试验中的作用、数据处理和管理的细节以及统计设计、问题和分析计划。公共健康相关性：拟议的 ATACH II 试验是一项为期五年的多中心随机 III 期试验，旨在确定早期强化抗高血压治疗对幕上脑出血 (ICH) 受试者急性高血压的疗效。这项大型、精简且集中的试验的主要假设是，使用尼卡地平静脉输注 24 小时强化收缩压 (SBP) 降低 (<140 mm Hg) 治疗组可降低死亡和残疾比例（定义为随机分组后 3 个月时，与接受标准 SBP 降低 (<180 mm Hg) 的治疗组相比，改良 Rankin 量表评分为 4-6) 的 ICH 患者在症状出现 3 小时。