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Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)

NCT05579626 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2026-01-07

No results posted yet for this study

Summary

This study is to evaluating the impact of low-intensity statin plus ezetimibe versus high-intensity statin therapy on risk of new-onset diabetes mellitus in patients with atherosclerotic cardiovascular disease who have prediabetes.

Conditions

Interventions

DRUG

high-intensity statin arm

•high-intensity statin strategy (standard arm): rosuvastatin 20 mg PO qd, once daily

DRUG

low-intensity statin plus ezetimibe

•low-intensity statin plus ezetimibe strategy (experimental arm): rosuvastatin 5mg /ezetimibe 10mg PO qd), once daily

Sponsors & Collaborators

  • Yuhan Corporation

    collaborator INDUSTRY

  • Seung-Whan Lee, M.D., Ph.D.

    lead OTHER

Principal Investigators

  • Seung-Whan Lee, MD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579626 on ClinicalTrials.gov