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

NCT ID: NCT04730648

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2023-04-23

Brief Summary

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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

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Conditions

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Lipid Metabolism Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PCSK9 inhibitor

Intervention Type DRUG

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PCSK9 inhibitor

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ying Li

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tangzhiming Li, PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Shenzhen People's Hospital, Shenzhen 518020, Guangdong, China

Locations

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Tangzhiming Li

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tangzhiming Li, PhD.

Role: CONTACT

+86 18588269277

Shaohong Dong, PhD.

Role: CONTACT

+86 13509633742

Facility Contacts

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Tangzhiming Li, PhD.

Role: primary

+86 18588269277

Shaohong Dong, PhD.

Role: backup

+86 13509633742

References

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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.

Reference Type DERIVED
PMID: 36017088 (View on PubMed)

Other Identifiers

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Among-Us study

Identifier Type: -

Identifier Source: org_study_id

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