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Clinical Trials/KCT0008541
KCT0008541
Not yet recruiting
未知

Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM

Samsung Medical Center0 sites6,000 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of the circulatory system
Sponsor
Samsung Medical Center
Enrollment
6000
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Subject must be at least 40 years of age.
  • 2\.Asymptomatic patients with presence of coronary calcification (Agatston Score \= 100\)
  • 3\.low\-density lipoproteins cholesterol (LDL\-C) \<190 mg/dL
  • 4\.A subject who voluntarily signed the Informed consent form

Exclusion Criteria

  • 1\.Objective evidence of at least moderate inducible ischemia requiring revascularization treatment
  • 2\.History of cerebrovascular disease
  • 3\.History of coronary or peripheral arterial revascularization
  • 4\.Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range
  • 5\.History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis)
  • 6\.Allergy or sensitivity to any statin or ezetimibe
  • 7\.Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
  • 8\.Pregnancy or breast feeding
  • 9\.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)
  • 10\.Unwillingness or inability to comply with the procedures described in this protocol.

Outcomes

Primary Outcomes

Not specified

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