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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0008362
Enrollment
200
Registered
2023-04-17
Start date
2023-04-04
Completion date
Unknown
Last updated
2023-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In randomization, 100 patients will proceed with Rochevastatin/Ezetimib 20/10 mg and 100 patients will proceed with Atovastatin/Ezetimib 40/10 mg. A new generation of drug elution stents can be

Sponsors

Yonsei University Yongin Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 in all 1-year blood tests

Secondary

MeasureTime frame
The rate at which LDL cholesterol is maintained at 55 mg/dL in the blood test after a month;Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary artery re-perfusion;Each secondary evaluation variable;Newly developed diabetes, difficulty in controlling sugar,;occurrence of statin-related muscle symptoms requiring therapeutic or dose changes;Increased muscle enzyme aberration (CPK > 4 x normal upper limit);Elevated liver enzyme levels (AST, ALT, or both = 3 x normal upper bound);Elevated serum creatine levels (from >50% baseline);Major bleeding (BARC type 2, 3, or 5);Reason for discontinuation or intolerance

Countries

Korea, Republic of

Contacts

Public ContactDeokKyu Cho

Yonsei University Yongin Severance Hospital

chodk123@yuhs.ac+82-31-5189-8755

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026