NCT05845424 High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
| NCT ID | NCT05845424 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Samsung Medical Center |
| Condition | Coronary Artery Calcification |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2023-07-03 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 6,000 participants in total. It began in 2023-07-03 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.
Eligibility 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.
Contact & Investigator
Seung-Hyuk Choi
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT05845424 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Coronary Artery Calcification. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05845424 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05845424 currently recruiting?
Yes, NCT05845424 is actively recruiting participants. Contact the research team at sh1214.choi@samsung.com for enrollment information.
Where is the NCT05845424 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05845424 clinical trial?
NCT05845424 is sponsored by Samsung Medical Center. The principal investigator is Seung-Hyuk Choi at Samsung Medical Center. The trial plans to enroll 6,000 participants.