PREVENTABLE Trial Implementation Phase

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ABSTRACT - Trial Implementation PREVENTABLE (PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults) will determine the effect of a moderate intensity statin on new dementia and disability-free survival in 20,000 community-dwelling participants age ≥75 years without atherosclerotic coronary heart disease or dementia. In addition, we will test the effect of a moderate intensity statin on reducing the CV composite (Hospitalization for MI/ACS, Stroke, or HF, CV revascularization or CV death) or the cognitive composite (MCI or dementia). The tolerability of statins will be determined by SAMS-CI, participant-report, and reason for stopping study drug. The Trial Implementation core will be under the leadership of Drs. Karen Alexander at DCRI and Jeff Williamson at WFSM. Together, our research team has substantial experience in pragmatic trial conduct, seamless implementation of the protocols, clinical trials in older adults, and assessment of cognitive and physical function. PREVENTABLE will be well positioned during trial implementation to enroll the right population, deliver the intervention, and efficiently and completely ascertain outcomes. We will draw on extensive and internationally recognized success in the development of study tools (CRF, ICF, manual of operations, enrollment materials), processes (IRB approval, data transfer, biospecimen transfer), communications (training materials, project meetings) and operational plans (data monitoring plan, site monitoring plan, poor enrollment mitigation plans). All of these must be finalized and disseminated before study start up. The Trial Implementation Core has the following specific aims: AIM 1. Randomize 20,000 community- dwelling ambulatory older adults (≥ 75 years) without dementia or CVD to atorvastatin 40mg or matching placebo. AIM 2. Deliver the intervention with a high degree of accuracy, adherence, and safety, with contingencies for stopping or resuming study drug based over the trial. AIM 3. Pragmatically collect health status of participants over time through linkage with EHR, Medicare, and NDI, and determine the new occurrence of dementia, MCI, or disability.