跳至主要内容
临床试验/NCT06568601
NCT06568601招募中不适用

Reducing Veterans' Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
410
试验地点
4
主要终点
Change in low density lipoprotein cholesterol

研究概览

简要总结

Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease (CVD) risk. However, many patients at high-risk for CVD do not accept or adhere to statins. This gap in patient's use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk. The main barriers to using statins are patients' perceived lack of benefit, excess risk of statin toxicity as well as their misperceptions of their CVD risk. Statin pharmacogenomic testing - an application of precision medicine - is a readily available, feasible, and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit and/or reduced risk of statin toxicity or increased risk for CVD. By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy, the investigators aim to improve patients' perceptions of their risk of CVD and statins and, in turn, their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk.

详细描述

Background: Despite the proven efficacy and safety of statins, nearly 250,000 Veterans at high-risk for cardiovascular disease (CVD) seen annually in primary care are not taking them leading to higher cholesterol levels, cardiovascular risk, and health care costs. Primary care providers and health systems have a critical and unmet need for pragmatic, scalable interventions to address gaps in their patients' perceptions of the risks and benefits of statin therapy to improve appropriate statin utilization and to lower CVD risk. Important prior work by the investigators group demonstrates that pharmacogenomic testing for statin toxicity is feasible, improves patients' perceptions of statin therapy, leads to a doubling in appropriate statin prescribing, and lowers cholesterol levels. The central hypothesis of this proposal is that disclosure of statin pharmacogenomic test results for statin efficacy/toxicity and CVD risk to patients at high-risk for CVD will improve their perceptions of their CVD risk and statins risks/benefits and, in turn, the proportion of Veterans accepting and adhering to statin therapy to achieve a clinically significant low-density lipoprotein cholesterol (LDL) reduction.

Significance: By using a feasible and inexpensive approach of pharmacogenomic testing for common genetic variants reporting on statin efficacy and toxicity and CVD risk, the work is significant as it will lead to more patients at high-risk for CVD accepting and adhering to statins. This work addresses HSR&D research priorities of quality and safety of health care and health care value, ORD priorities of increasing substantial real-world impact of VA research, and VHA quality measures around statin prescribing and controlling cholesterol levels in patients at high-risk for CVD.

Innovation and Impact: This proposal uses an innovative approach of pharmacogenomic testing to address patients' perceptions of the risks and benefits of statin therapy and their risk of CVD which are known barriers to statin acceptance and adherence. The investigators expect a positive impact on reducing CVD risk in Veterans.

Specific Aims:

  1. Reduce cholesterol levels through a precision medicine approach of statin pharmacogenomic testing.
  2. Improve acceptance of guideline-directed statin therapy through delivery of statin pharmacogenomic test results that communicates statin efficacy and toxicity.
  3. Identify contextual and economic factors salient for implementing statin pharmacogenomic testing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be included in the analysis if they:
  • Are a Veteran
  • Aged 40-75 years
  • Diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral artery disease)
  • An upcoming primary care appointment in the next 4 months
  • No active statin prescription (any time/dose, VA, or non-VA) in the prior 6 months
  • English speaking
  • At least 1 current active VA prescription
  • At least 1 primary care appointment within the prior 2 years

排除标准

  • Non-Veterans
  • End-stage renal disease
  • History of rhabdomyolysis
  • Active treatment for non-dermatologic cancer
  • Known, prior SLCO1B1 genetic test results
  • Liver cirrhosis
  • Palliative care or hospice in 1-year prior to admission, during hospital stay, or at discharge
  • Active prescription for PCSK9 inhibitor
  • Inability to provide informed consent due to language impairment, cognitive disease, or other similar factors at the discretion of the research assistant or project coordinator.
  • Active enrollment in a different, interventional clinical trial, at the discretion of PI.
  • History of allogeneic stem cell transplant or liver transplant.
  • Documentation of specific adverse drug reactions thought to be attributed to statins:
  • Myopathy with associated elevation in creatinine kinase > 10x upper limit of normal
  • Angioedema
  • Elevated AST/ALT
  • Others at discretion of PI

研究组 & 干预措施

Genetic testing arm

Experimental

The intervention involves: genetic testing; interpretation; and prior to and shortly following an upcoming appointment, communication to patients and providers about the patients' predicted statin efficacy and toxicity, genetic risk for CVD, and individualized recommended statin type/dose.

干预措施: Pharmacogenetic and polygenic risk testing (Genetic)

Control

Active Comparator

The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).

干预措施: Active control (Other)

结局指标

主要结局

Change in low density lipoprotein cholesterol

时间窗: 15-months

The primary effectiveness outcome will be the change in LDL-cholesterol level from baseline to 15-months.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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