Using genetic testing to improve statin use in Veterans with high cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance the acceptance and adherence to statin therapy among Veterans at high risk for cardiovascular disease (CVD) by utilizing pharmacogenomic testing. The approach involves identifying patients who may benefit from statins or are at risk for statin toxicity through genetic testing. By communicating these results to patients, the study seeks to improve their understanding of their CVD risk and the benefits of statin therapy. The ultimate goal is to increase the proportion of patients who accept and adhere to statin treatment, leading to better cholesterol management and reduced cardiovascular risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients will be included in the analysis if they:

* Are a Veteran
* 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

Exclusion Criteria:

* 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 aspartate transferase (AST)/alanine transaminase (ALT)
  * Others at discretion of principal investigator (PI)

Where it's running

• Richard L. Roudebush VA Medical Center, Indianapolis, IN
  Indianapolis, Indiana, United States Recruiting
• Durham VA Medical Center, Durham, NC
  Durham, North Carolina, United States Not yet recruiting

Study contacts

• Principal investigator: Deepak Voora, MD — Durham VA Medical Center, Durham, NC
• Study coordinator: Deepak Voora, MD
• Email: deepak.voora@va.gov
• Phone: (919) 286-0411

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VERVE-102 for adults with or at high risk for heart disease

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• Enlicitide (MK-0616) for adults with high cholesterol in India

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• Pemafibrate in people with high cholesterol not fully controlled by statins

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• Dual PCSK9 Inhibition in secondary prevention for high LDL-C with statin intolerance

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• Moderate-Intensity Statin + Ezetimibe vs High-Intensity Statin in CKD with ASCVD

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  Recruiting Yonsei University · Seoul · NCT07524101

• Corn oil versus avocado oil effects on cardiometabolic risk factors

  This trial will test whether following controlled diets containing either corn oil or avocado oil for 21 days changes cardiometabolic risk factors in adults with mildly to moderately high non‑HDL cholesterol.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.