ACHIEVE Pilot Statins for Vascular Protection

Not yet recruiting

• Conditions: ASCVD
• Interventions: Other: Pharmacist call

• Registration Number: NCT06551701
• Lead Sponsor: Duke University

Brief Summary

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 Timeline

• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Start: 2025-04-15
• Primary Completion: 2025-05-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• 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

Exclusion Criteria

• Hemodialysis
• History of rhabdomyolysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No statin	Pharmacist call	Patients who are identified with ASCVD who do not take a statin or do not take the recommended dose.

Primary Outcome Measures

Name	Time	Method
Provider engagement as measured by recruitment	2 years	The goal is recruiting at least 25% of identified providers.
Patient engagement as measured by recruitment	2 years	The goal is to recruit at least 30% of identified patients overall and within the black population

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States