ASCVDACHIEVENCT06551701
ACHIEVE Pilot Statins for Vascular Protection
An observational study of ASCVD, run by Duke University at 2 sites in United States.
Trial summary
ACHIEVE aims to increase statin usage among patients with ASCVD by having a pharmacist talk to patients and providers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ASCVD
- What is being tested?
- Pharmacist call
- How many people
- 225 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients who have an ASCVD diagnosis but are currently not treated with a moderate-high intensity statin.
Who may be able to join
- Patients with a diagnosis of atherosclerotic cardiovascular disease currently not treated with a moderate- high intensity statin and the providers that care for them.
- Patient age 18-75
Who cannot join
- Hemodialysis
- History of rhabdomyolysis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Clinical Research Institute
Durham, North Carolina, 27701
Carelon Research
Wilmington, Delaware, 19801
About this study
Official title: A Cluster-randomized Trial to Improve Use of High IntEnsity Statins for Vascular Protection
ACHIEVE aims to increase statin usage among patients with ASCVD by having a pharmacist talk to patients and providers.
Read the detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the United States (U.S.) Statins reduce the risk of cardiovascular events by 30% in those with prior history of ASCVD. Despite being inexpensive and well-tolerated, however, statins are underused in clinical practice, particularly in patients who identify as Black. A large-scale intervention to improve evidence-based statin initiation among individuals with ASCVD is needed, particularly for the Black population. To meet this need, we aim to conduct a multi-center, pragmatic, cluster randomized, controlled trial to assess the impact of a provider- and patient-directed intervention to increase the prescription of, and adherence to, appropriate statin therapy among those with ASCVD (ACHIEVE: A Controlled trial to improve use of High IntEnsity statins for Vascular protEction). The intervention will be pharmacist-led, embedded in commercial payer systems, partnering with the National Committee for Quality Assurance (NCQA), and with a particular emphasis on improving statin use in the Black population.
- Conditions
- ASCVD
- Being tested
- Pharmacist call
- Keywords
- Statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist callOther
Pharmacists will call patients and their providers to discuss benefits of statin use
| Study group | Role | What they receive |
|---|---|---|
| No statin | Patients who are identified with ASCVD who do not take a statin or do not take the recommended dose. Receives: Other: Pharmacist call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider engagement as measured by recruitment
The goal is recruiting at least 25% of identified providers.
Measured: 2 years
Patient engagement as measured by recruitment
The goal is to recruit at least 30% of identified patients overall and within the black population
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start19 May 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASCVDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Carelon Research, Harvard Pilgrim Health Care, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christopher Granger, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551701
- Sponsor's protocol ID
- Pro00114111
- Other IDs
- 1R34HL166680-01A1
- Acronym
- ACHIEVE
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide requested unrestricted data to parties who sign a data sharing agreement which stipulates that data must be: 1) used solely for research purposes, 2) properly acknowledged in resulting publications, 3) kept confidential and inaccessible to third parties, and 4) destroyed or returned after analyses are completed. Additionally, users must agree not to use data to identify individual participants. Letters of agreement will be executed so that research materials can be provided to not-for-profit institutions. The study team further agrees that all resource sharing agreements comply with the Bayh-Dole Act of 1980 and the Technology Transfer Commercialization Act of 2000. We will not be using model organisms.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Trial to Improve Use of High IntEnsity Statins for Vascular Protection
- ClinicalTrials.gov ID
- NCT06551701
- Acronym / sponsor ID
- ACHIEVE / Pro00114111
- Conditions
- ASCVD
- Keywords
- Statin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Carelon Research, Harvard Pilgrim Health Care, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ACHIEVE aims to increase statin usage among patients with ASCVD by having a pharmacist talk to patients and providers.
Detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the United States (U.S.) Statins reduce the risk of cardiovascular events by 30% in those with prior history of ASCVD. Despite being inexpensive and well-tolerated, however, statins are underused in clinical practice, particularly in patients who identify as Black. A large-scale intervention to improve evidence-based statin initiation among individuals with ASCVD is needed, particularly for the Black population. To meet this need, we aim to conduct a multi-center, pragmatic, cluster randomized, controlled trial to assess the impact of a provider- and patient-directed intervention to increase the prescription of, and adherence to, appropriate statin therapy among those with ASCVD (ACHIEVE: A Controlled trial to improve use of High IntEnsity statins for Vascular protEction). The intervention will be pharmacist-led, embedded in commercial payer systems, partnering with the National Committee for Quality Assurance (NCQA), and with a particular emphasis on improving statin use in the Black population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No statin | – | Other: Pharmacist callPatients who are identified with ASCVD who do not take a statin or do not take the recommended dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients who have an ASCVD diagnosis but are currently not treated with a moderate-high intensity statin.
Key inclusion criteria (2 listed)
- Patients with a diagnosis of atherosclerotic cardiovascular disease currently not treated with a moderate- high intensity statin and the providers that care for them.
- Patient age 18-75
Key exclusion criteria (2 listed)
- Hemodialysis
- History of rhabdomyolysis
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 callPharmacists will call patients and their providers to discuss benefits of statin use | Other | No statin |
Primary outcome
Provider engagement as measured by recruitment
Time frame: 2 years
The goal is recruiting at least 25% of identified providers.
Patient engagement as measured by recruitment
Time frame: 2 years
The goal is to recruit at least 30% of identified patients overall and within the black population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. We will provide requested unrestricted data to parties who sign a data sharing agreement which stipulates that data must be: 1) used solely for research purposes, 2) properly acknowledged in resulting publications, 3) kept confidential and inaccessible to third parties, and 4) destroyed or returned after analyses are completed. Additionally, users must agree not to use data to identify individual participants. Letters of agreement will be executed so that research materials can be provided to not-for-profit institutions. The study team further agrees that all resource sharing agreements comply with the Bayh-Dole Act of 1980 and the Technology Transfer Commercialization Act of 2000. We will not be using model organisms.
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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.
Christopher Granger, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASCVD, run by Duke University at 2 sites 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 2 inclusion and 2 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Provider engagement as measured by recruitment (time frame: 2 years). The study lists 2 primary outcomes in all. 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 1 Jul 2026.