Aggressive cholesterol-lowering treatment for asymptomatic patients with coronary calcification
Official title: Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination Versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM (DECISION-CAL)
Run by Samsung Medical Center · NCT05845424 · Data updated 2026-11-12
This study is testing whether a strong cholesterol-lowering treatment can help people over 40 with heart calcification avoid heart problems, even if they don't have any symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | July 3, 2023 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2030 |
| Registry record updated | January 14, 2025 |
| Trial ID | NCT05845424 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are asymptomatic individuals aged 40 and older with coronary calcification and LDL-C levels below 190 mg/dL.
✕Probably not a fit
Patients with a history of significant cardiovascular disease or those with contraindications to statin therapy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the safety and efficacy of a high-intensity statin combined with ezetimibe against the current standard lipid-lowering treatment in asymptomatic patients who have coronary calcification. It focuses on individuals aged 40 and older with an Agatston Score of 100 or higher and LDL-C levels below 190 mg/dL. The research seeks to determine if this aggressive treatment approach can effectively reduce the risk of cardiovascular events in patients without existing cardiovascular disease. The study is conducted at Samsung Medical Center in Seoul.
Why it matters
Potential benefit: If successful, this treatment could significantly lower the risk of cardiovascular events in asymptomatic patients with coronary calcification.
How similar studies have gone: Previous studies have shown success with aggressive lipid-lowering strategies in secondary prevention, but this approach for primary prevention in asymptomatic patients is less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must be at least 40 years of age. * Asymptomatic patients with presence of coronary calcification (Agatston Score ≥ 100) * low-density lipoproteins cholesterol (LDL-C) \<190 mg/dL Exclusion Criteria: * Objective evidence of at least moderate inducible ischemia requiring revascularization treatment * History of cerebrovascular disease * History of coronary or peripheral arterial revascularization * Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range * History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis) * Allergy or sensitivity to any statin or ezetimibe * Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine * Pregnancy or breast feeding * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * Unwillingness or inability to comply with the procedures described in this protocol.
Where it's running
-
SamsungMedicalCenter
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Seung-Hyuk Choi — Samsung Medical Center
- Study coordinator: Seung-Hyuk Choi, MD
- Email: sh1214.choi@samsung.com
- Phone: 82-2-3410-3419
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.