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

• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05298475
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Statin; Drug: PCSK9 inhibitor; Drug: PCSK9 inhibitor	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Statin-only group The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn).	Drug: Statin; Medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn)
Experimental: Low-dose PCSK9 inhibitor group The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor once a month SC.	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
Experimental: Normal-dose PCSK9 inhibitor group The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor twice a month SC.	Drug: Statin; Medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn); Drug: PCSK9 inhibitor; 1 injection of PCSK9 inhibitor twice a month SC

Outcome Measures

Primary Outcome Measures

1. The level of total cholesterol(TC) [6 month]

   The level of total cholesterol(TC) at 6 month

2. The level of triglyceride(TG) [6 month]

   The level of triglyceride(TG) at 6 month

3. The level of high-density lipoprotein cholesterol(HDL-C) [6 month]

   The level of high-density lipoprotein cholesterol(HDL-C) at 6 month

4. The level of low-density lipoprotein cholesterol(LDL-C) [6 month]

   The level of low-density lipoprotein cholesterol(LDL-C) at 6 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Aged 18-85 years, gender unlimited;

2. Diagnosed with acute coronary syndrome;

3. The fasting LDL-C≥1.8mmol/L (70mg/dL);

4. Subjects participated in the study voluntarily and signed informed consent.

Exclusion Criteria:

1. Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg；

2. Last known left ventricular ejection fraction < 30%

3. Known hemorrhagic stroke at any time；

4. Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening；

5. Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times；

6. LDL or plasma apheresis within 12 months prior to randomization；

7. Pregnant or lactating women；

8. Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years；

9. Patients allergic to PCSK9 inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

• The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05298475
• Other Study ID Numbers: EPICS-CHACS
• First Posted: Mar 28, 2022
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Affiliated Hospital with Nanjing Medical University: Acute coronary syndrome; Serum lipids; PCSK9 inhibitor; Statin
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of Mar 28, 2022