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New treatment option for Coronary Artery Calcification
Official title High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
ClinicalTrials.gov ID: NCT05845424
What this study is testing
What is Guideline directed statin therapy?
Guideline directed statin therapy is an investigational medicine, being studied as a potential treatment for coronary artery calcification.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.