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

November 20, 2025 updated by: Deok-Kyu Cho, Yonsei University

A Randomized comparaTive Study Of Rosuvastatin/Ezetimibe 20/10mg and Atorvastatin/Ezetimibe 40/10mg in Patients With Coronary Artery Drug eLuting stEnt Implantation Requiring High-dose stAtin/Ezetimibe combiNaTion Therapy: TOLERANT Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Death from vascular disease accounts for about one-third of all causes of death. Important regulatory factors in cardiovascular disease include dyslipidemia, high blood pressure, and diabetes, and keeping LDL cholesterol low among dyslipidemia levels, especially after cardiovascular stent treatment, is an essential factor to prevent another event in the future. Statin is currently the most widely used LDL cholesterol control drug with multifunctional effects such as controlling inflammatory reactions, controlling the movement and proliferation of vascular smooth muscle cells, and inhibiting the production of blood clots in addition to LDL cholesterol control.In addition, in several clinical studies, statins have shown many effects in primary and secondary prevention of cardiovascular disease, and several studies have been published that lower LDL cholesterol results in more benefits. Based on these findings, the 2016 European Heart Association (ESC), 2018 American Heart Association (ACC), and most recently changed 2022 Korean guidelines recommend controlling LDL cholesterol to <55mg/dL for patients with coronary artery disease. However, high-dose statins alone are still difficult to maintain for a long time due to increased liver levels, diabetes, and muscle pain, and recently, a drug that lowers LDL cholesterol has been developed in the small intestine called Ezetimib and is widely used in combination with statins in actual clinical trials. In fact, the RACING trial published in LANCET for domestic patients reported that the combination of moderate-intensity statins (Rosuvastatin 10mg) and ezetimib had fewer side effects for three years and better compliance, resulting in a better rate of maintaining LDL cholesterol at 70mg/dL or less than high-intensity statins alone. However, in this study, the rate at which LDL cholesterol remained below 55 mg/dL after one year was only 42% for moderate statins/esetimibe and 25% for high-intensity statins, and remained similar for three years. Therefore, high-intensity statins and ezetimibes may be essential treatments to reduce LDL cholesterol to less than 55 mg/dL and more than 50% under the current new guidelines. High-strength statins usually refer to more than 40 mg of atovastatin and 20 mg of Rosuvastatin, and drugs that combine ezetimibe with these high-strength statins are currently widely used to lower LDL cholesterol to 55 mg/dL or less if there are no special side effects in clinical practice, but research on compliance is very insufficient. This study aims to observe the rate of discontinuation or intolerance in patients taking Rosuvastatin/Ezetimib 20/10mg and Atovastatin/Ezetimib 40/10mg, with no previous comparison, RACING trial reported a 5% rate of discontinuation at rosuvastain 20mg administered, and atovatin/10mg/10mg. Referring to On the use of a pilot sample for sample size determination. the hospital conducts about 60 PCI cases a month, and about 1/5 of them are expected to be able to enroll 100 patients per group for about two years to conduct a total of 200 patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
    • Gyeonggi-do
      • Yongin, Gyeonggi-do, South Korea, 16995
        • Yongin Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: rosuvastatin/ezetimibe 20/10mg
rosuzet 10/20mg
Drug: 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.
Active Comparator: atorvastatin/ezetimibe 40/10mg
NB zet 10/40mg
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of statins changed
Time Frame: 12 months
Percentage of statins changed to discontinuation or intolerance (muscle pain, muscle efficiency, elevated liver level, etc.) within a year
12 months
Rate at which LDL cholesterol remains below 55 mg/dL
Time Frame: 12 months
Rate at which LDL cholesterol remains below 55 mg/dL in all 1-year blood tests
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: 12 months
Cardiovascular death
12 months
The rate at which LDL cholesterol is maintained at 55 mg/dL in the blood test after a month
Time Frame: 1 months
The rate at which LDL cholesterol is maintained at 55 mg/dL in the blood test after a month
1 months
number of non-fatal myocardial infarction
Time Frame: 12 months
number of non-fatal myocardial infarction
12 months
number of non-fatal stroke
Time Frame: 12 months
number of non-fatal stroke
12 months
number of coronary artery re-perfusion
Time Frame: 12 months
number of coronary artery re-perfusion
12 months
number of Newly developed diabetes or difficulty in controlling sugar
Time Frame: 12 months
number of Newly developed diabetes or difficulty in controlling sugar
12 months
occurrence of statin-related muscle symptoms requiring therapeutic or dose changes
Time Frame: 12 months
occurrence of statin-related muscle symptoms requiring therapeutic or dose changes
12 months
Increased muscle enzyme aberration
Time Frame: 12 months
Increased muscle enzyme aberration (CPK > 4 x normal upper limit)
12 months
Elevated liver enzyme levels
Time Frame: 12 months
Elevated liver enzyme levels (AST, ALT, or both ≥ 3 x normal upper bound)
12 months
Elevated serum creatine levels
Time Frame: 12 months
Elevated serum creatine levels (from >50% baseline)
12 months
number of Major bleeding
Time Frame: 12 months
number of Major bleeding
12 months
number of people who stopped taking the drug
Time Frame: 12 months
number of people who stopped taking the drug
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
dotter

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yongcheol Kim, MD, Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9-2023-0008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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