2/2 REPRIEVE Extension for Trial Completion

2/2 REPRIEVE 延期以完成试验

• 批准号: 10479471
• 负责人: Michael Tse-Yin Lu
• 金额: $ 124.36万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10479471
• 关键词: AIDS clinical trial group; Address; Ancillary Study; Angiography; Authorization documentation; Biological Assay; Biological Markers; Biology; Blood; Blood Vessels; COVID-19 pandemic; Cardiovascular Diseases; Cardiovascular system; Clinical; Clinical Data; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Collection; Companions; Computers; Coronary artery; Data; Data Analyses; Data Analytics; Data Collection; Data Coordinating Center; Data Reporting; Disease; Electronic Mail; Enrollment; Ensure; Epidemiology; Equation; Event; HIV; Heart Diseases; Information Dissemination; Infrastructure; Investments; Knowledge; Laboratories; Lead; Leadership; Letters; Methodology; Morphology; Myocardial Infarction; National Heart, Lung, and Blood Institute; Outcome; Participant; Persons; Placebo Control; Preparation; Prevention strategy; Primary Prevention; Procedures; Process; Publications; Quality Control; Randomized; Reporting; Research; Research Design; Risk; SARS-CoV-2 infection; Site; Statistical Data Interpretation; Stroke; Structure; System; Time; Training; United States National Institutes of Health; X-Ray Computed Tomography; adjudication; archive data; cardiovascular disorder prevention; cardiovascular disorder risk; cohort; coronary computed tomography angiography; coronavirus disease; data acquisition; data archive; data exchange; data management; data repository; data sharing; design; efficacy evaluation; follow-up; high risk; imaging study; immune activation; inflammatory marker; medical specialties; meetings; pragmatic trial; prevent; primary endpoint; protocol development; randomized trial; response; stroke event; tool; trial design; vascular inflammation

Project Summary/Abstract This proposal will support the Data Coordinating Center (DCC) for the Randomized Trial to Prevent Vascular Events in HIV Trial (REPRIEVE) Extension for up to two additional years, with an additional year for study close-out. This additional time is necessary to collect the major adverse cardiovascular events (MACE) required to ensure adequate power to address the primary aim of REPRIEVE, to determine the efficacy of statins as a primary cardiovascular prevention strategy in HIV. Completion of the trial will protect the value of the initial NIH investment and leverage existing REPRIEVE infrastructure, with its data analytical and oversight structures. This DCC proposal is a companion to the REPRIEVE Clinical Coordinating Center (CCC) proposal. REPRIEVE is a multicenter, randomized, placebo controlled, pragmatic trial investigating the efficacy of statins for primary prevention of cardiovascular disease (CVD) events (primary endpoint) in 7,770 persons with HIV (PWH) without known CVD and with low to moderate CVD risk as per the 2013 ACC/AHA Pooled Cohort Equations, (referred to as ASCVD risk). To understand the biology of statin effects, 805 participants were co- enrolled in an embedded mechanistic substudy that will determine the effects of statins on non-calcified plaque volume and high risk plaque morphology using coronary computed tomographic angiography (CTA), as well as on blood biomarkers of vascular inflammation and immune activation after 4 months and two years. Further, in response to the global SARS-CoV-2 pandemic, REPRIEVE will address critical knowledge gaps regarding the epidemiology of SARS-CoV-2 infection and COVID-related CVD complications among PWH, and determine the protective statin effects for COVID disease across the globe. In the proposed extension, the REPRIEVE DCC will continue to provide methodological and logistical support for the collection, quality control, and analysis of data including rigorous, timely, and independent adjudication of potential MACE events. Furthermore, the DCC remains responsible for statistical design and analysis, assistance in protocol development, data management, CTA data acquisition and interpretation, biospecimen analysis, and electronic communications.

项目总结/摘要 本提案将支持数据协调中心（DCC）开展预防血管性心脏病随机试验。 HIV试验（REPRIEVE）延长期内的事件最多可延长2年，其中1年用于研究 收尾这一额外时间对于收集主要心血管不良事件（MACE）是必要的 需要确保有足够的权力来解决剥夺的主要目的，以确定 他汀类药物作为HIV患者心血管疾病的主要预防策略。完成试验将保护 最初的NIH投资，并利用现有的REPRIEVE基础设施，其数据分析和监督 结构.本DCC提案是REPRIEVE临床协调中心（CCC）提案的配套提案。 REPRIEVE是一项研究他汀类药物疗效的多中心、随机、安慰剂对照、实用性试验 在7，770名HIV感染者中进行心血管疾病（CVD）事件的一级预防（主要终点） (PWH)根据2013年ACC/AHA汇总队列，无已知CVD且有低至中度CVD风险 公式，（称为ASCVD风险）。为了了解他汀类药物的生物学效应，805名参与者被共同研究。 入组了一项嵌入式机制子研究，该研究将确定他汀类药物对非钙化斑块的影响 使用冠状动脉计算机断层扫描血管造影（CTA）的体积和高风险斑块形态，以及 在4个月和2年后对血管炎症和免疫激活的血液生物标志物的影响。进一步 为了应对全球SARS-CoV-2大流行，REPRIEVE将解决有关 PWH中SARS-CoV-2感染和COVID相关CVD并发症的流行病学，并确定 他汀类药物对地球仪的新型冠状病毒病的保护作用。 在拟议的延长期内，保留发展协调委员会将继续提供方法和后勤支助， 用于数据的收集、质量控制和分析，包括严格、及时和独立的裁定 潜在的MACE事件。此外，发展协调委员会仍然负责统计设计和分析， 协助方案制定、数据管理、CTA数据采集和解读、生物标本 分析和电子通信。