NCT05298475

Low-dose PCSK9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome

Short-term Effect of Modified 、Low-dose Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome : the Singe-center 、Real-world Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 patients had fasting serum low-density lipoprotein (LDL-C) \>1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C,taking the LDL-C reduction ≥50% from the baseline, LDL-C\<1.8mmol/L (70mg/dL), and LDL-C\<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.

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 in Chinese with the acute coronary syndrome (ACS), to provide evidence for the use of this drug in real-world Chinese populations. This study will provide more economical, convenient, and acceptable treatment options. 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 patients had fasting serum low-density lipoprotein (LDL-C) \>1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C, taking the LDL-C reduction ≥50% from the baseline, LDL-C\<1.8mmol/L (70mg/dL), and LDL-C\<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Statin	Medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn)
DRUG	PCSK9 inhibitor	1 injection of PCSK9 inhibitor once a month SC
DRUG	PCSK9 inhibitor	1 injection of PCSK9 inhibitor twice a month SC

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

1 site across 1 country: China