Status:
COMPLETED
Effects of Statin for Elderly Patients With Atherosclerotic Cardiovascular Disease
Lead Sponsor:
Korea University Anam Hospital
Conditions:
Atheroscleroses, Coronary
Eligibility:
All Genders
70+ years
Phase:
PHASE4
Brief Summary
High-dose statins can reduce mortality and cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD). Therefore, US and European recommendations recommend that ...
Detailed Description
Established Atherosclerotic Cardiovascular Disease (ASCVD) A. Coronary artery disease meeting at least one of the following criteria: * A history of coronary recanalization in multivessel coronary a...
Eligibility Criteria
Inclusion
- Inclusion Criteria (must satisfy all of the following selection criteria) :
- Those who are 70 years of age or older as of the date of consent
- Established arteriosclerotic cardiovascular disease (coronary artery disease, cerebrovascular disease, or peripheral vascular disease)
- Subjects who have consented to the study plan and follow-up observation by the patient or representative, and who consented in advance in writing to the clinical subject consent approved by the research deliberation committee/ethics committee of the research institution
- Exclusion Criteria:
- Take statins or ezetimibe within the last 4 weeks
- In case of end-stage kidney disease (eGFR\<30 ml/min/1.73m2)
- Heart surgery or major surgery is planned within the next 6 months
- Patients with chronic diseases such as severe lung disease, stroke, etc.
- Patients with chronic inflammatory diseases who require oral, intravenous, or intra-articular steroid treatment (Ointments, inhalants, or intranasal steroids are allowed)
- If you have been diagnosed with cancer within the past 1 year or are currently receiving chemotherapy
- In the case of clinically significant abnormal findings that may infringe on the safety of the study by the investigator's judgment confirmed in a screening visit, physical examination, blood test, or electrocardiogram
- Liver disease, bile duct obstruction, or liver enzyme level (ALT/AST) is more than 3 times normal
- If you have a disease whose life expectancy is less than 1 year
- If you do not want or cannot comply with the procedure described in the research proposal
Exclusion
Key Trial Info
Start Date :
August 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT04826354
Start Date
August 11 2021
End Date
June 28 2023
Last Update
August 8 2023
Active Locations (2)
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1
Kangbuk Samsung Hospital
Seoul, South Korea
2
Korea University Anam Hospital
Seoul, South Korea