2/2 REPRIEVE Extension for Trial Completion
2/2 REPRIEVE 延期以完成试验
基本信息
- 批准号:10479471
- 负责人:
- 金额:$ 124.36万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AIDS clinical trial groupAddressAncillary StudyAngiographyAuthorization documentationBiological AssayBiological MarkersBiologyBloodBlood VesselsCOVID-19 pandemicCardiovascular DiseasesCardiovascular systemClinicalClinical DataClinical TrialsClinical Trials Data Monitoring CommitteesCollaborationsCollectionCompanionsComputersCoronary arteryDataData AnalysesData AnalyticsData CollectionData Coordinating CenterData ReportingDiseaseElectronic MailEnrollmentEnsureEpidemiologyEquationEventHIVHeart DiseasesInformation DisseminationInfrastructureInvestmentsKnowledgeLaboratoriesLeadLeadershipLettersMethodologyMorphologyMyocardial InfarctionNational Heart, Lung, and Blood InstituteOutcomeParticipantPersonsPlacebo ControlPreparationPrevention strategyPrimary PreventionProceduresProcessPublicationsQuality ControlRandomizedReportingResearchResearch DesignRiskSARS-CoV-2 infectionSiteStatistical Data InterpretationStrokeStructureSystemTimeTrainingUnited States National Institutes of HealthX-Ray Computed Tomographyadjudicationarchive datacardiovascular disorder preventioncardiovascular disorder riskcohortcoronary computed tomography angiographycoronavirus diseasedata acquisitiondata archivedata exchangedata managementdata repositorydata sharingdesignefficacy evaluationfollow-uphigh riskimaging studyimmune activationinflammatory markermedical specialtiesmeetingspragmatic trialpreventprimary endpointprotocol developmentrandomized trialresponsestroke eventtooltrial designvascular inflammation
项目摘要
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.
项目概要/摘要
该提案将支持数据协调中心 (DCC) 进行预防血管性心脏病的随机试验
HIV 试验 (REPRIEVE) 中的事件最多可再延长两年,并额外延长一年的研究时间
结束。需要额外的时间来收集主要不良心血管事件 (MACE)
需要确保有足够的权力来实现 REPRIEVE 的主要目标,以确定 REPRIEVE 的有效性
他汀类药物作为艾滋病毒主要心血管预防策略。完成试验将保护其价值
NIH 的初始投资并利用现有的 REPRIEVE 基础设施及其数据分析和监督
结构。该 DCC 提案是 REPRIEVE 临床协调中心 (CCC) 提案的配套提案。
REPRIEVE 是一项多中心、随机、安慰剂对照、实用性试验,调查他汀类药物的疗效
用于对 7,770 名 HIV 感染者进行心血管疾病 (CVD) 事件的一级预防(主要终点)
(PWH) 没有已知的 CVD 且根据 2013 年 ACC/AHA 合并队列具有低至中度 CVD 风险
方程(称为 ASCVD 风险)。为了了解他汀类药物效应的生物学原理,805 名参与者共同参与了
参加了一项嵌入式机械亚研究,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) 测量体积和高风险斑块形态,以及
4 个月和两年后血管炎症和免疫激活的血液生物标志物的变化。进一步地,在
为了应对全球 SARS-CoV-2 大流行,REPRIEVE 将解决有关以下方面的关键知识差距:
PWH 中 SARS-CoV-2 感染和 COVID 相关 CVD 并发症的流行病学,并确定
他汀类药物对全球新冠肺炎的保护作用。
在拟议的延期中,REPRIEVE DCC 将继续提供方法和后勤支持
用于数据的收集、质量控制和分析,包括严格、及时和独立的裁决
潜在的 MACE 事件。此外,DCC 仍然负责统计设计和分析,
协助方案开发、数据管理、CTA 数据采集和解释、生物样本
分析和电子通信。
项目成果
期刊论文数量(0)
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会议论文数量(0)
专利数量(0)
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