Ireland
--:--IST
Active, not recruiting Phase 4

Comparative Study of Rosuvastatin/Ezetimib 20/10 mg and Atovastatin/Ezetimib 40/10 mg (TOLERANT Trial)

NCT05910476 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2023-05-03
Last updated
2025-11-25

Condition(s) studied

Coronary Artery DiseaseDyslipidemias

Investigational drug(s) / intervention(s)

a high dose of statin/ezetimib

a high dose of statin/ezetimib: In randomization, 100 patients will proceed with Rosuvastatin/Ezetimib 20/10 mg and 100 patients will proceed with Atovastatin/Ezetimib 40/10 mg. A new generation of drug elution stents can be inserted and later registered, and if the patient agrees to participate in the study, they are randomly assigned after stent implantation.

Study summary

the investigators would like to compare the differences between roschvastin and atovastatin in patients who require high-dose statin/ejetimib to undergo a new generation of drug elution stent implantation for cardiovascular disease and maintain LDL cholesterol below 55 mg/dL.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 19 years of age or older 2. Patients who underwent a new generation of drug elution stent implantation for cardiovascular disease Exclusion Criteria: 1. LDL cholesterol levels below 55 mg/dL without statin treatment 2. Serum AST/ALT with an acute liver disease within a month or a normal upper limit that is not continuously explained 3. Allergies or overreactions to statins 4. Estimated Dawn of Less than 1 Year 5. If it is determined that follow-up is not possible for more than one year 6. Pregnancy

Primary outcome measure(s)

  • Percentage of statins changed — 12 months
    Percentage of statins changed to discontinuation or intolerance (muscle pain, muscle efficiency, elevated liver level, etc.) within a year
  • Rate at which LDL cholesterol remains below 55 mg/dL — 12 months
    Rate at which LDL cholesterol remains below 55 mg/dL in all 1-year blood tests

Trial sites (1)

FacilityCityRegionStatus
Yongin Severance Hospital Yongin Gyeonggi-do
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05910476 on ClinicalTrials.gov ↗ ← All trials in South Korea