Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06767774

Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus

Led by Korea University Anam Hospital · Updated on 2025-04-27

2000

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

Sponsors

K

Korea University Anam Hospital

Lead Sponsor

D

Daewon Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The AVOID-DM trial is a multicenter, prospective, randomized study comparing the risk of new-onset diabetes mellitus (DM) between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). The study evaluates pitavastatin plus ezetimibe combination therapy versus high-intensity statin monotherapy (rosuvastatin 20 mg). Enrolling 2,000 non-diabetic participants with ASCVD, subjects are randomized 1:1 into the two treatment arms. The primary outcome is the incidence of new-onset DM over a follow-up period of up to 36 months. Secondary outcomes include cardiovascular events, changes in LDL cholesterol, fasting glucose, HbA1c, and insulin resistance. This trial hypothesizes that the combination therapy will achieve LDL targets with a lower risk of new-onset DM compared to high-intensity statin monotherapy.

CONDITIONS

Official Title

Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Not taking oral hypoglycemic agents (OHAs) and have fasting glucose below 126 mg/dL
  • HbA1c less than 6.5%
  • Plasma glucose less than 200 mg/dL after 2 hours during a 75 g oral glucose tolerance test
  • Established atherosclerotic cardiovascular disease, including at least one of: documented myocardial infarction, history of coronary revascularization with 50% or more artery stenosis, stroke of atherosclerotic origin, carotid revascularization with 50% or more carotid artery stenosis, symptomatic peripheral arterial disease with intermittent claudication and ankle-brachial index of 0.90 at rest, peripheral artery stenosis of 50% or more, history of peripheral artery revascularization, or lower extremity amputation due to atherosclerosis
  • On a stable diet before randomization and able to adhere to the National Cholesterol Education Program Therapeutic Lifestyle Change diet or equivalent
  • Provided written informed consent approved by the institutional review board or ethics committee
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or of childbearing potential
  • Concomitant use of strong CYP3A4 or CYP2C9 inhibitors
  • Chronic kidney disease with eGFR less than 30 ml/min/1.73m2 or dialysis-dependent renal failure
  • Uncontrolled hypothyroidism
  • Personal or family history of inherited muscle disorders
  • History of statin-induced muscle toxicity
  • Alcohol dependence
  • Hypersensitivity to statins or ezetimibe
  • Hemodynamic instability including cardiogenic shock, refractory ventricular arrhythmia, or NYHA class IV heart failure
  • History of hemorrhagic stroke, intracranial hemorrhage, TIA, or ischemic stroke within past 6 months
  • Planned surgery requiring stopping statins or ezetimibe within 6 months
  • Current active cancer treatment
  • Significant abnormal findings at screening that may interfere with safe study completion
  • Liver disease or biliary obstruction with elevated liver enzymes or bilirubin
  • Life expectancy under 1 year from cardiac or noncardiac causes
  • Unwillingness or inability to comply with study procedures
  • Previously diagnosed diabetes mellitus treated with lifestyle modification and oral hypoglycemic agents or insulin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Korea University Anam Hospital

Seoul, South Korea, 02841

Actively Recruiting

Loading map...

Research Team

C

Cheol Woong Yu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here