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New treatment option for Hypercholesterolemia
Official title Pharmacogenomic Informed Statin Prescribing
ClinicalTrials.gov ID: NCT06568601
What this study is testing
What is Pharmacogenetic and polygenic risk testing?
Pharmacogenetic and polygenic risk testing is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for hypercholesterolemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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
You likely can't join if
- Non-Veterans
- End-stage renal disease
- History of rhabdomyolysis
- Active treatment for non-dermatologic cancer
- Known, prior SLCO1B1 genetic test results
- Liver cirrhosis
See the full eligibility criteria
- 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
- 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, treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.