ACHIEVE Pilot Statins for Vascular Protection (ACHIEVE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ASCVD
• Intervention / Treatment: Other: Pharmacist call

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 Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19801
      • Carelon Research
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients who have an ASCVD diagnosis but are currently not treated with a moderate-high intensity statin.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No statin; Patients who are identified with ASCVD who do not take a statin or do not take the recommended dose.	Other: Pharmacist call; Pharmacists will call patients and their providers to discuss benefits of statin use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider engagement as measured by recruitment	The goal is recruiting at least 25% of identified providers.	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	2 years

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Harvard Pilgrim Health Care; Carelon Research
• Investigators: Principal Investigator: Christopher Granger, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Actual): July 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Statin
• Other Study ID Numbers: Pro00114111; 1R34HL166680-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be shared after publication of the final manuscript and will continue until the data from the main study is available for sharing.
• IPD Sharing Access Criteria: Unrestricted access will be provided to parties who sign a standard data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No