Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2020
CompletedFirst Posted
Study publicly available on registry
January 29, 2021
CompletedStudy Start
First participant enrolled
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2023
CompletedMay 5, 2022
May 1, 2022
1 year
November 26, 2020
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
cardiovascular prognosis
composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina and heart failure.
52 weeks
Study Arms (2)
pcsk9 inhibitor group
EXPERIMENTALpatients 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 INTERVENTIONPatients 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.
Interventions
For newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection.
Eligibility Criteria
You may qualify if:
- New diagnosis ACS patient by serum biomarker and coronary arteriography.
You may not qualify if:
- Severe renal dysfunction acute or chronic bacterial and viral infections sleep apnea cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tangzhiming Li
Shenzhen, Guangdong, 518020, China
Related Publications (1)
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: 36017088DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Tangzhiming Li, PhD.
Department of Cardiology, Shenzhen People's Hospital, Shenzhen 518020, Guangdong, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 26, 2020
First Posted
January 29, 2021
Study Start
April 22, 2021
Primary Completion
April 23, 2022
Study Completion
April 23, 2023
Last Updated
May 5, 2022
Record last verified: 2022-05