Metabolic Syndrome Clinical Trial
— DECISION-CALOfficial 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)
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.
Status | Not yet recruiting |
Enrollment | 6000 |
Est. completion date | June 30, 2030 |
Est. primary completion date | June 30, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiovascular events | a composite of death from any causes, myocardial infarction, stroke, unplanned coronary revascularization, or other arterial revascularization procedure | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | All-cause death | Death from any causes | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Cardiovascular death | Death from cardiovascular causes | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Stroke | Ischemic or hemorrhagic stroke | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Unplanned coronary revascularization | revascularization procedure to coronary artery | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Arterial revascularization procedure | All arterial revascularization procedure | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Major bleeding | Bleeding Academic Research Consortium (BARC) type 3-5 | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Bleeding | BARC type 2-5 | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Heart failure hospitalization | Hospitalization due to heart failure | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Coronary calcium progression | Delta CAC | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Changes of LDL-C | Delta LDL-C | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | New-onset diabetes mellitus | Occurence of new-onset diabetes mellitus | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Hepatic disorder requiring discontinuation of statin | Occurence of hepatic disorder requiring discontinuation of statin | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | muscle-related adverse events | Occurence of muscle-related adverse events due to statin | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Proportion of patients with LDL-C < 100mg/dL | Proportion of patients with LDL-C < 100mg/dL | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) | |
Secondary | Proportion of patients with LDL-C < 70mg/dL | Proportion of patients with LDL-C < 70mg/dL | up to 4.5 years of median follow-up (till 3 year after the last patient enrollment) |
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