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
Not Applicable
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008362
- Lead Sponsor
- Yonsei University Yongin Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200
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 & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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