HyperlipidemiaNCT06647238
Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention
A study testing Pharmacist Intervention in lipid therapy in people with Hyperlipidemia and Coronary Artery Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia, Coronary Artery Disease
- What is being tested?
- Pharmacist Intervention in lipid therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of coronary artery disease
- low-density lipoprotein (LDL) > 55
- Primary Care Physician at 1 of 6 identified clinics
Who cannot join
- Patients who are no longer an active patient of one of the internal medicine practices
- Patients whose cholesterol is managed by another practice
- Women of childbearing age/potential
- Patients residing in hospice/Long Term Care facilities
- End-stage liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Cabarrus
Concord, North Carolina, 28025
About this study
Official title: Second Time's the Charm: Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention
The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.
Read the detailed description
Studies have shown prevention of cardiovascular adverse events is directly proportional to percent reduction in low-density lipoprotein (LDL). This evidence explains why LDL targets for secondary prevention have continued to be lowered. Cholesterol guidelines have been updated recently and encourage the use of multiple lipid lowering therapies, in addition to statins, for secondary prevention. However, these novel agents can be expensive and difficult to acquire, making prescribing challenging for providers.
- Conditions
- Hyperlipidemia, Coronary Artery Disease
- Being tested
- Pharmacist Intervention in lipid therapy
- Keywords
- Pharmacist intervention, Hyperlipidemia treatment, secondary prevention of cardiovascular disease
- Medical subject headings
- Hyperlipidemias, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Intervention in lipid therapyOther
Pharmacist intervention may include but is not limited to prescribing (statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, etc.), patient education, and medication access.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Intervention | Experimental | Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia. Receives: Other: Pharmacist Intervention in lipid therapy |
| Control | No intervention | Chart review only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55)
patients with LDL within goal (<55) (yes/no)
Measured: Month 5
Secondary outcomes (3)
Percent Change in Low-density Lipoprotein (LDL)
Percent LDL reduction (will use baseline LDL and lowest LDL)
Measured: Baseline to end of study period up to Month 5
Number of Participants With Medications Initiated or Titrated
Number of Medications initiated or titrated
Measured: Baseline to end of study period up to Month 5
Prevalence of Elevated Lipoprotein(a)
Number of Subjects with Prevalence of elevated Lipoprotein(a)
Measured: Baseline to end of study period up to Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start5 Nov 2024
- Primary completion1 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control group will not directly interact with investigators. Will perform retrospective chart review only.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kayla Marvin, PharmD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647238
- Sponsor's protocol ID
- IRB00118029
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Time's the Charm: Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention
- ClinicalTrials.gov ID
- NCT06647238
- Acronym / sponsor ID
- IRB00118029
- Conditions
- Hyperlipidemia, Coronary Artery Disease
- Keywords
- Pharmacist intervention, Hyperlipidemia treatment, secondary prevention of cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.
Detailed description
Studies have shown prevention of cardiovascular adverse events is directly proportional to percent reduction in low-density lipoprotein (LDL). This evidence explains why LDL targets for secondary prevention have continued to be lowered. Cholesterol guidelines have been updated recently and encourage the use of multiple lipid lowering therapies, in addition to statins, for secondary prevention. However, these novel agents can be expensive and difficult to acquire, making prescribing challenging for providers.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group will not directly interact with investigators. Will perform retrospective chart review only.
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Intervention | Experimental | Other: Pharmacist Intervention in lipid therapyPharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia. |
| Control | No intervention | –Chart review only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of coronary artery disease
- low-density lipoprotein (LDL) > 55
- Primary Care Physician at 1 of 6 identified clinics
Key exclusion criteria (5 listed)
- Patients who are no longer an active patient of one of the internal medicine practices
- Patients whose cholesterol is managed by another practice
- Women of childbearing age/potential
- Patients residing in hospice/Long Term Care facilities
- End-stage liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist Intervention in lipid therapyPharmacist intervention may include but is not limited to prescribing (statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, etc.), patient education, and medication access. | Other | Pharmacist Intervention |
Primary outcome
Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55)
Time frame: Month 5
patients with LDL within goal (<55) (yes/no)
3 secondary outcomes
Percent Change in Low-density Lipoprotein (LDL)
Time frame: Baseline to end of study period up to Month 5
Number of Participants With Medications Initiated or Titrated
Time frame: Baseline to end of study period up to Month 5
Prevalence of Elevated Lipoprotein(a)
Time frame: Baseline to end of study period up to Month 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kayla Marvin, PharmD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Intervention in lipid therapy in people with Hyperlipidemia and Coronary Artery Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55) (time frame: Month 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.