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

NCT05298475 | Unknown Phase 4

• 1 other identifier: EPICS-CHACS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; Serum lipids; PCSK9 inhibitor; Statin

Outcome Measures

Primary Outcomes (4)

• The level of total cholesterol(TC)

  The level of total cholesterol(TC) at 6 month

  6 month

• The level of triglyceride(TG)

  The level of triglyceride(TG) at 6 month

  6 month

• The level of high-density lipoprotein cholesterol(HDL-C)

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

  6 month

• The level of low-density lipoprotein cholesterol(LDL-C)

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

  6 month

Study Arms (3)

Statin-only group

EXPERIMENTAL

The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn).

Drug: Statin

Low-dose PCSK9 inhibitor group

EXPERIMENTAL

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; Drug: PCSK9 inhibitor

Normal-dose PCSK9 inhibitor group

EXPERIMENTAL

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; Drug: PCSK9 inhibitor

Interventions

Statin DRUG

Medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn)

Low-dose PCSK9 inhibitor group; Normal-dose PCSK9 inhibitor group; Statin-only group

PCSK9 inhibitor DRUG

1 injection of PCSK9 inhibitor once a month SC

Low-dose PCSK9 inhibitor group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Central Study Contacts

Liansheng Wang

CONTACT

+86 13390787111; jsyzcxw@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

CN (1)