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

Sponsor

Shenzhen People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04730648

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lipid Metabolism Cardiovascular Diseases	Drug: PCSK9 inhibitor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Apr 22, 2021

Actual Primary Completion Date :

Apr 23, 2022

Anticipated Study Completion Date :

Apr 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pcsk9 inhibitor group 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.	Drug: PCSK9 inhibitor For newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection.
No Intervention: control group Patients with comparable age, sex ratio, and BMI, but coronary arteries are relatively normal evaluated by coronary angiography. their blood and urine would be collected as the control group.

Arm

Intervention/Treatment

Experimental: pcsk9 inhibitor group

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.

Drug: PCSK9 inhibitor

For newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection.

No Intervention: control group

Patients with comparable age, sex ratio, and BMI, but coronary arteries are relatively normal evaluated by coronary angiography. their blood and urine would be collected as the control group.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tangzhiming Li	Shenzhen	Guangdong	China	518020

Sponsors and Collaborators

Shenzhen People's Hospital

Investigators

Principal Investigator: Tangzhiming Li, PhD., Department of Cardiology, Shenzhen People's Hospital, Shenzhen 518020, Guangdong, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ying Li, professor, Shenzhen People's Hospital

ClinicalTrials.gov Identifier:

NCT04730648

Other Study ID Numbers:

Among-Us study

First Posted:

Jan 29, 2021

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Myocardial Infarction

Angina, Unstable

Infarction

Study Results

No Results Posted as of May 5, 2022