ACHIEVE Pilot Statins for Vascular Protection

NCT ID: NCT06551701

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-19

Study Completion Date

2026-02-28

Brief Summary

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ACHIEVE aims to increase statin usage among patients with ASCVD by having a pharmacist talk to patients and providers.

Detailed Description

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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

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ASCVD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No statin

Patients who are identified with ASCVD who do not take a statin or do not take the recommended dose.

Pharmacist call

Intervention Type OTHER

Pharmacists will call patients and their providers to discuss benefits of statin use

Interventions

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Pharmacist call

Pharmacists will call patients and their providers to discuss benefits of statin use

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carelon Research

OTHER

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Granger, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Carelon Research

Wilmington, Delaware, United States

Site Status

Duke Clinical Research Institute

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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1R34HL166680-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00114111

Identifier Type: -

Identifier Source: org_study_id

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