Comparing two medications for lowering cholesterol in heart disease patients
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
This study is testing whether a combination of Rosuvastatin and Ezetimib works better than Atorvastatin and Ezetimib to lower cholesterol in heart disease patients who have had a stent placed.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin, Gyeonggi-do) |
| Trial ID | NCT05910476 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Rosuvastatin combined with Ezetimib versus Atorvastatin combined with Ezetimib in patients who have undergone drug-eluting stent implantation for coronary artery disease. The focus is on maintaining low LDL cholesterol levels below 55 mg/dL to prevent future cardiovascular events. The study will evaluate the safety and efficacy of these high-dose statin and Ezetimib combinations in managing dyslipidemia in this patient population. Participants will be monitored for their cholesterol levels and any adverse effects during the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who have undergone drug-eluting stent implantation for cardiovascular disease.
Not a fit: Patients with LDL cholesterol levels below 55 mg/dL without statin treatment or those with acute liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment regimen for managing cholesterol levels in patients with coronary artery disease, potentially reducing the risk of future cardiovascular events.
How similar studies have performed: Previous studies have shown positive outcomes with similar approaches in managing cholesterol levels in cardiovascular patients, indicating that this study builds on established findings.
Eligibility criteria
Show full inclusion / exclusion 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: 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
Where this trial is running
Yongin, Gyeonggi-do
- Yongin Severance Hospital — Yongin, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: deok kyu CHO, MD
- Email: CHODK123@yuhs.ac
- Phone: +82-31-5189-8755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.