PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
对老年人降脂的事件和益处进行务实评估(可预防)
基本信息
- 批准号:10697297
- 负责人:
- 金额:$ 1564.43万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-30 至 2027-08-31
- 项目状态:未结题
- 来源:
- 关键词:Alzheimer&aposs disease related dementiaAlzheimer&aposs disease riskAncillary StudyBenefits and RisksBiochemicalBlood VesselsCapsicumCardiologyCardiovascular systemCaringCessation of lifeClassificationClinicalClinical ResearchClinical TrialsClinical Trials DesignCognitiveComparative StudyCoronary heart diseaseDataData ScienceDementiaDetectionDiabetes MellitusEffectivenessElderlyEquipoiseEthnic OriginEvaluationEventExclusionFundingFutureGenomicsGeriatricsGinkgo bilobaGoalsHealthHealth StatusHealthcare SystemsHeart DiseasesHeart failureHeterogeneityHigh PrevalenceHospitalizationHyperlipidemiaImageImpaired cognitionImpairmentInformation DisseminationInfrastructureInternationalIntervention TrialKnowledgeLeadLeadershipLife ExpectancyLipidsMedicalMemoryMethodologyMethodsMuscleMyocardial InfarctionOlder PopulationOutcomeParticipantPatientsPharmaceutical PreparationsPhysical FunctionPlacebo ControlPolypharmacyPopulationPopulation HeterogeneityPragmatic clinical trialPrecision HealthPreventionPrimary PreventionRecurrenceReportingRiskRoleSafetySpecimenStrokeSubgroupSymptomsUnited States National Institutes of HealthVascular Cognitive ImpairmentVascularizationVeterans Health Administrationacute coronary syndromebiobankblood pressure interventioncardiovascular risk factorclinical carecollaboratorycomorbiditydesigndisabilityevidence baseexperiencefrailtyfunctional outcomeshuman subjectimprovedinsightmedical schoolsmild cognitive impairmentmultiple chronic conditionspatient populationpragmatic trialpreservationpreventprimary outcomeracial diversityrecruitsafety testingsuccesssurvival outcomesystems research
项目摘要
There is an urgent need for evidence to guide clinical care of older adults due to demographic shifts, including
longer life expectancy and a recent doubling of the older adult population. Statins reduce recurrent CVD events
and prevent initial events in patients younger than 75 years. However, clinical research has often excluded
persons older than 75 years due to a higher prevalence of comorbidity and frailty so little to no evidence is
available to guide care in this population. For older adults living longer, the promise of preventing cognitive
impairment is as compelling as preventing a CVD event, but some evidence suggests statins may
contribute to memory difficulty or muscle symptoms. There is equipoise regarding the usefulness of statins
for primary CVD, dementia, and disability prevention in adults older than 75 years, especially in the setting
of multiple chronic conditions, advanced age, or frailty. Evidence to improve cognitive and functional
outcomes in older populations with diverse race/ethnicity and health status will require new clinical trial
approaches with sustainable methodology and infrastructure. We propose PREVENTABLE (PRagmatic
EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults), the first statin trial with a non-CVD
primary outcome—survival free of dementia or persisting disability. Using a placebo-controlled pragmatic
clinical trial (PCT) design across PCORnet and VA network, the trial will be under the leadership of Dr. Karen
Alexander at DCRI, Dr. Jeff Williamson at WFSM, Dr. Adrian Hernandez at DCRI, and Dr. Walter Ambrosius at
WFSM. This team has established experience and track-record of accomplishment in the design and conduct
of PCTs, trial expertise in ascertaining cognitive and disability outcomes in older adults, and is supported by a
robust administrative infrastructure for coordinating these shared responsibilities for success. The overarching
goal of PREVENTABLE is to generate knowledge about the role of statins in older adults, a population in which
risk/benefit for primary prevention has been under studied. The hypothesis is that a large trial conducted in an
older adult population will demonstrate the benefit of statins for reducing dementia, disability, and CV events.
We further hypothesize that extensive genomic, biochemical and imaging ancillary studies will offer unique
insights into these key outcomes. PREVENTABLE has the following specific aims: AIM 1: Determine the role
of a moderate-intensity statin in preventing dementia and prolonging disability-free survival in patients 75 years
and older without clinically evident coronary heart disease, including those with frailty, impaired physical
function, mild cognitive impairment, polypharmacy, and multi-morbidity. AIM 2: Determine the role of moderate-
intensity statin in preventing hospitalization for myocardial infarction/acute coronary syndrome, stroke, heart
failure, revascularization or cardiovascular-related death, and preventing either mild cognitive impairment or
dementia. AIM 3: Test the safety and tolerability of statins in older adults and collect 17,000 bio-specimens to
advance precision health.
由于人口结构的变化,迫切需要证据来指导老年人的临床护理,包括
更长的预期寿命和最近老年人口翻了一番。他汀类药物减少复发的心血管事件
并防止75岁以下患者的初始事件。然而,临床研究往往排除了
75岁以上的人,由于共病和虚弱的患病率较高,所以很少或没有证据表明
可用于指导这一人群的护理。对于寿命更长的老年人来说,防止认知障碍的承诺
损害与预防心血管事件一样令人信服,但一些证据表明他汀类药物可能
会导致记忆困难或肌肉症状。他汀类药物的用处是平衡的
用于75岁以上成年人的主要心血管疾病、痴呆症和残疾预防,特别是在
患有多种慢性病、高龄或虚弱的。改善认知和功能的证据
不同种族/民族和健康状况的老年人群的结果将需要新的临床试验
采用可持续的方法和基础设施的方法。我们提出可预防的(务实的
老年人降脂事件和益处的评估),第一个非心血管疾病的他汀类药物试验
主要结果--无痴呆症或持续性残疾的生存。使用安慰剂控制的务实
临床试验(PCT)设计跨越PCORnet和VA网络,试验将在Karen博士的领导下进行
DCRI的Alexander、WFSM的Jeff Williamson博士、DCRI的禤浩焯·埃尔南德斯博士和Walter Ambrosius博士
WFSM。这个团队在设计和实施方面已经建立了经验和成就记录
在PCT中,试验专门知识用于确定老年人的认知和残疾结果,并得到
强大的行政基础设施,用于协调这些共同承担的成功责任。最重要的是
可预防的目标是产生关于他汀类药物在老年人中作用的知识,在老年人中,
初级预防的风险/益处一直在研究中。假设是一个大型试验在一个
老年人群将证明他汀类药物在减少痴呆症、残疾和心血管事件方面的好处。
我们进一步假设,广泛的基因组、生化和影像辅助研究将提供独特的
对这些关键结果的洞察。可预防的有以下具体目标:目标1:确定作用
中等强度他汀类药物在预防痴呆和延长患者75年无残疾生存期中的作用
以及没有临床明显冠心病的老年人,包括那些虚弱、身体受损的人
功能障碍、轻度认知障碍、多药联用和多种疾病。目标2:确定适度-
强度他汀类药物预防心肌梗死/急性冠脉综合征、中风、心脏住院
衰竭、血运重建或心血管相关死亡,并预防轻度认知障碍或
痴呆症。目标3:测试他汀类药物在老年人中的安全性和耐受性,并收集17,000个生物标本以
推进精准健康。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Aligning the 4Ms of Age-Friendly Health Systems With Statin Use for Primary Prevention.
将老年友好型卫生系统 4M 与他汀类药物用于一级预防相结合。
- DOI:10.1111/jgs.16325
- 发表时间:2020
- 期刊:
- 影响因子:6.3
- 作者:Shah,RajC;Supiano,MarkA;Greenland,Philip
- 通讯作者:Greenland,Philip
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KAREN P ALEXANDER其他文献
KAREN P ALEXANDER的其他文献
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{{ truncateString('KAREN P ALEXANDER', 18)}}的其他基金
PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
对老年人降脂的事件和益处进行务实评估(可预防)
- 批准号:
10259715 - 财政年份:2019
- 资助金额:
$ 1564.43万 - 项目类别:
PREVENTABLE Administrative and Trial Management
可预防的行政和审判管理
- 批准号:
10259716 - 财政年份:2019
- 资助金额:
$ 1564.43万 - 项目类别:
PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)
对老年人降脂的事件和益处进行务实评估(可预防)
- 批准号:
10021540 - 财政年份:2019
- 资助金额:
$ 1564.43万 - 项目类别:
PREVENTABLE Administrative and Trial Management
可预防的行政和审判管理
- 批准号:
10697299 - 财政年份:2019
- 资助金额:
$ 1564.43万 - 项目类别:
PREVENTABLE Administrative and Trial Management
可预防的行政和审判管理
- 批准号:
10021543 - 财政年份:2019
- 资助金额:
$ 1564.43万 - 项目类别: