Actively Recruiting

Phase 4
Age: 19Years +
All Genders
NCT06722521

GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification

Led by Asan Medical Center · Updated on 2025-08-07

7435

Participants Needed

1

Research Sites

381 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification

CONDITIONS

Official Title

GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 years and older
  • Asymptomatic patients with significant coronary calcification (Agatston score 2424 100) and no physiologically significant coronary artery disease
  • Coronary CT scan used to establish the calcification score performed within 3 years prior to randomization
  • Physiological significance assessment done within 6 months prior to randomization
  • Eligible regardless of prior statin or anti-platelet use
Not Eligible

You will not qualify if you...

  • History of major atherosclerotic cardiovascular disease events such as acute coronary syndrome, coronary revascularization, ischemic stroke (not TIA), or symptomatic peripheral arterial disease
  • Presence of moderate to severe coronary artery disease with positive stress test or fractional flow reserve less than 0.8
  • Familial hypercholesterolemia
  • LDL cholesterol 2424 190 mg/dL regardless of statin use
  • Requirement to continue PCSK9 inhibitor during the trial
  • Chronic kidney disease with estimated glomerular filtration rate below 30 mL/min/1.73m2
  • Advanced liver disease (Child-Pugh B or C)
  • Significant liver enzyme elevation or biliary tract obstruction
  • Recent history (within 6 months) of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage
  • Organ transplant recipients on immunosuppressive therapy
  • Concurrent use of medications increasing bleeding risk such as NOAC or warfarin
  • History of significant allergic reaction to aspirin or statin/ezetimibe
  • Diagnosis or treatment for cancer (except superficial skin cancer) within past 3 years
  • Life expectancy less than 1 year from any cause
  • Pregnancy, breastfeeding, or child-bearing potential
  • Clinically significant abnormalities at screening that preclude safe study completion
  • Unwillingness or inability to comply with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Asan Medical Center

Seoul, South Korea

Actively Recruiting

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Research Team

S

Seung-Whan Lee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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