PREVENTABLE Vanguard Phase

先锋阶段对于早期成功招募和保留参与者、提供研究干预以及确定主要和次要结果至关重要。先锋阶段的主要目标是实施、审查和完善试验过程，确保成功入组，以满足NIH的期望，并确认试验的计划性成功。该试验将确定中等强度他汀类药物在预防痴呆（包括阿尔茨海默病和阿尔茨海默病相关痴呆）和延长75岁及以上无临床明显冠心病（包括虚弱、身体功能受损、轻度认知障碍、多种药物和多种疾病）患者的无残疾生存期中的作用。在研究开始时，PCORnet的目标为bb0 - 90%， VA的目标为bb1 - 80%，其余的目标将在不久之后随机化。我们将跟踪招募和留住具有可用人口代表性的参与者的能力。我们将根据SPRINT、adaptive、ACCORD、WHIMS和LIFE等试验实施培训和监测，以确保干预措施的成功实施。特别关注的将是邮购药房的运营指标、霍桑效应和视频同意过程。我们将确定和/或判定CV死亡和HFpEF验证研究支持的结果。在这一阶段，可预防研究还将仔细跟踪早期随访损失，从数据集市和医疗保险中获得诊断，以及交叉率，并改进流程以最大限度地减少研究风险，并通知任何修改。先锋阶段核心将由。DCRI的凯伦·亚历山大和WFSM的杰夫·威廉姆森。在这一阶段，我们将仔细跟踪早期的随访损失和交叉率，并在可能的情况下完善过程，以尽量减少这些损失，并对研究程序进行必要的修改。在Vanguard阶段，我们预计会出现7000个随机结果（75%的里程碑是5250个随机结果）。站点激活、招聘和保留基准对于指导早期工作也至关重要。先锋阶段有以下具体目标：目标1：证明招募和留住年龄≥75岁无心血管疾病或痴呆的可预防代表参与者的能力。目标2。证明有能力提供干预措施，并以高度的准确性确定结果。目标3：根据观察到的随动损失和交叉速率证明保留功率。

The Vanguard phase is critical to early demonstration of successful recruitment and retention of participants, delivery of the study intervention, and ascertainment of the primary and secondary outcomes. The primary goal of the Vanguard Phase is to implement, review and refine trial processes and ensure successful enrollment to meet NIH expectations and confirm programmatic success of the trial. This trial will determine the role of a moderate-intensity statin in preventing dementia, including Alzheimer’s disease and Alzheimer’s disease-related dementias, 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. A target of >90% of PCORnet and >80% of VA sites will be ready to randomize at study start with the remaining sites ready to randomize shortly thereafter. We will track the ability to recruit and retain participants who are representative of the available population. We will implement training and monitoring adapted from trials such as SPRINT, ADAPTABLE, ACCORD, WHIMS, and LIFE, to ensure successful delivery of the intervention. Of particular focus will be the operational metrics for the mail-order pharmacy, Hawthorne Effect, and video consent process. We will ascertain and/or adjudicate outcomes supported by validation studies for CV death and HFpEF. During this phase, PREVENTABLE will also carefully track early loss to follow-up, obtainable diagnoses from data marts and Medicare, and crossover rates, and refine processes to minimize risks to the study and inform any modifications. The Vanguard Phase Core will be under the leadership of Drs. Karen Alexander of DCRI and Jeff Williamson of WFSM. During this phase, we will carefully track early loss to follow-up and cross-over rates and refine processes for minimizing these when possible and make any needed modifications to the study procedures. We project 7,000 randomizations during the Vanguard phase (5,250 randomizations is the 75% milestone). Site activation and recruitment and retention benchmarks will also be vital for directing early efforts. The Vanguard phase has the following specific aims: AIM 1: Demonstrate the ability to recruit and retain participants in PREVENTABLE representative of those age≥75 years of age without CVD or dementia. AIM 2. Demonstrate the ability to deliver the intervention and ascertain outcomes with a high degree of accuracy. AIM 3: Demonstrate preserved power based on observed lost to follow up and cross over rates.