Comparing usual dose rosuvastatin with ezetimibe to high-dose rosuvastatin for heart disease
The Effect of Usual Dose Rosuvastatin Plue Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque: A Randomized Controlled Trial
This study is testing whether a regular dose of rosuvastatin combined with ezetimibe can help reduce heart plaque better than a high dose of rosuvastatin alone for people with heart disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03169985 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a usual dose of rosuvastatin combined with ezetimibe versus a high dose of rosuvastatin alone in modifying coronary atherosclerotic plaque. It is a prospective, open-label, randomized study conducted at a single center, focusing on patients with moderate coronary artery stenosis who are deferred to medical treatment. The study will assess the impact of these treatment regimens on cholesterol levels and plaque reduction, considering the potential side effects associated with high-dose statin therapy. The findings could provide insights into alternative treatment strategies for patients with coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing coronary angiography for suspected ischemic heart disease with moderate stenosis who are suitable for medical treatment.
Not a fit: Patients with severe renal failure, active liver disease, or those on certain medications like niacin or fibrates may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and effective alternative treatment for patients with coronary artery disease, potentially reducing the risk of side effects associated with high-dose statin therapy.
How similar studies have performed: Previous studies have shown success with similar approaches, particularly the IMPROVE-IT study, which demonstrated the benefits of combining statins with ezetimibe.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Among patients who undergo CAG for suspected ischemic heart disease and meet all of the followings: * Moderate stenosis (30-70%) in coronary artery * Deferred to medical treatment based on physiologic (FFR, CFR, IMR) or radiologic (IVUS with or without OCT) evaluation. * Agreement obtained by participant Exclusion Criteria: * Severe renal failure(glomerular filtration rate \< 30 ml/min/1.73m2, hemodialysis or peritoneal dialysis) * Active liver disease * Patient taking Niacin or fibrate(if possible, patient can be enrolled to the study after stopping those medication) * Medical or family history of myositis, unexplained CK elevation \> 3 times ULN at first visit * Life expectancy \< 2 years (judged by investigator) * Coadministration of cyclosporine * Untreated hypothyroidism * Patient with poor compliance including alcohol abuse * History of hypersensitivity including myotoxicity for either statin or ezetimibe * Pregnant or breast-feeding woman * Other conditions inappropriate for enrollment by investigator * \* Eligible patients will be randomly assigned to treatment arms, stratified by diagnosis on admission(acute coronary syndrome or stable ischemic heart disease) and presence of chronic statin use (more than one month)
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Joo-Yong Hahn, MD, PhD
- Email: ichjy1@gmail.com
- Phone: 82-2-3410-6653
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.