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

NCT04730648 — Not applicable, Unknown, 100 participants, Shenzhen People's Hospital

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Registry	NCT04730648
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, screening
Enrollment	100 (Estimated)
Sponsor	Shenzhen People's Hospital (Other)
Conditions	Lipid Metabolism, Cardiovascular Diseases
Interventions	PCSK9 inhibitor (Drug)
Dates	start 2021-04-22, primary completion 2022-04-23, completion 2023-04-23 (estimated), first posted 2021-01-29, last updated 2022-05-05
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
pcsk9 inhibitor group	Experimental	Drug: 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.
control group	No intervention		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.

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Tangzhiming Li	Shenzhen, Guangdong	China	Recruiting

+Publications

Results publication: Ou Z, Yu Z, Liang B, Zhao L, Li J, Pang X, Liu Q, Xu C, Dong S, Sun X, Li T. Evolocumab enables rapid LDL-C reduction and inflammatory modulation during in-hospital stage of acute coronary syndrome: A pilot study on Chinese patients. Front Cardiovasc Med. 2022 Aug 9;9:939791. doi: 10.3389/fcvm.2022.939791. eCollection 2022. PMID 36017088

+Investigators

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

My Notes

Public

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