Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study

Not Applicable

• Conditions: Lipid Metabolism; Cardiovascular Diseases
• Interventions: Drug: PCSK9 inhibitor

• Registration Number: NCT04730648
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

Acute coronary syndrome (ACS) is a lethal disease, reduced low-density lipoprotein (LDL) cholesterol due to inhibition of proprotein convertase subtilisin/kexin 9 (PCSK9) reduces cardiovascular events and improve cardiovascular prognosis. we assuming that PCSK9 inhibitor could bring metabolic change in serum, in order to investigate the metabolic modification, we conduct this clinical trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-04-22
• Primary Completion: 2022-04-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05
• Study Completion: 2023-04-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• New diagnosis ACS patient by serum biomarker and coronary arteriography.

Exclusion Criteria

• Severe renal dysfunction acute or chronic bacterial and viral infections sleep apnea cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pcsk9 inhibitor group	PCSK9 inhibitor	patients with severe coronary stenosis diagnosed ACS. The baseline blood and urine would be collected, thereafter, the PCSK9 inhibitor would be injected. 64-72 hours after, the blood and urine sample collection would be performed.

Primary Outcome Measures

Name	Time	Method
cardiovascular prognosis	52 weeks	composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina and heart failure.

Trial Locations

Locations (1)

Tangzhiming Li; 🇨🇳 Shenzhen, Guangdong, China