Status:
UNKNOWN
Low-dose PCSK9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. These pati...
Detailed Description
Purpose:The purpose of this study was to explore the short-term effect of a modified, lower-than-guideline-recommended doses of PCSK9 inhibitors combined with a statin in the treatment of dyslipidemia...
Eligibility Criteria
Inclusion
- Aged 18-85 years, gender unlimited;
- Diagnosed with acute coronary syndrome;
- The fasting LDL-C≥1.8mmol/L (70mg/dL);
- Subjects participated in the study voluntarily and signed informed consent.
Exclusion
- Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) \> 180 mmHg or diastolic BP (DBP) \> 110 mmHg；
- Last known left ventricular ejection fraction \< 30%
- Known hemorrhagic stroke at any time；
- Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 at final screening；
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times；
- LDL or plasma apheresis within 12 months prior to randomization；
- Pregnant or lactating women；
- Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years；
- Patients allergic to PCSK9 inhibitors.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05298475
Start Date
April 1 2022
End Date
April 1 2024
Last Update
March 28 2022
Active Locations (1)
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1
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029