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Genetic Testing

Pharmacogenomic Testing for High Cholesterol

N/A
Waitlist Available
Led By Deepak Voora, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 40-75 years
Diagnosed with diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral artery disease)
Must not have
Active prescription for PCSK9 inhibitor
Liver cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15-months
Awards & highlights

Summary

This trial aims to address the issue of high-risk cardiovascular disease patients not accepting or sticking to statin medication, even though it is cost-effective in reducing cholesterol levels and CVD risk. The main barriers

Who is the study for?
This trial is for individuals with high cholesterol who are at risk for cardiovascular disease (CVD) but may be hesitant to take statins due to concerns about their effectiveness or potential side effects. Participants should not currently be on statin therapy.
What is being tested?
The study tests whether genetic testing can help predict the benefits and risks of taking statins, potentially improving patient acceptance and adherence by personalizing treatment plans based on individual genetic profiles.
What are the potential side effects?
While specific side effects are not detailed here, common ones associated with statins include muscle pain, digestive problems, increased blood sugar levels, and neurological symptoms like memory loss or confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 75 years old.
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I have been diagnosed with diabetes or heart/blood vessel disease.
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I currently have an active prescription from the VA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently prescribed a PCSK9 inhibitor medication.
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I have liver cirrhosis.
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I have had rhabdomyolysis in the past.
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I am currently receiving treatment for a cancer that is not skin cancer.
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I have not been under palliative or hospice care in the last year.
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I have had a stem cell or liver transplant.
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My kidneys are in the final stage of failure.
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I know my SLCO1B1 genetic test results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in low density lipoprotein cholesterol

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Genetic testing armExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,660 Total Patients Enrolled
Deepak Voora, MDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
3 Previous Clinical Trials
365 Total Patients Enrolled
~273 spots leftby May 2027
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