Back to resultsAcute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
Primary Purpose
Lipid Metabolism, Cardiovascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PCSK9 inhibitor
Sponsored by
About this trial
This is an interventional screening trial for Lipid Metabolism
Eligibility Criteria
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
Sites / Locations
- Tangzhiming LiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pcsk9 inhibitor group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
cardiovascular prognosis
composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina and heart failure.
Secondary Outcome Measures
Full Information
NCT ID
NCT04730648
First Posted
November 26, 2020
Last Updated
May 4, 2022
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04730648
Brief Title
Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
Official Title
Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
April 23, 2022 (Actual)
Study Completion Date
April 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism, Cardiovascular Diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pcsk9 inhibitor group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PCSK9 inhibitor
Intervention Description
For newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection.
Primary Outcome Measure Information:
Title
cardiovascular prognosis
Description
composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina and heart failure.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tangzhiming Li, PhD.
Phone
+86 18588269277
Email
litangzhiming@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaohong Dong, PhD.
Phone
+86 13509633742
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tangzhiming Li, PhD.
Organizational Affiliation
Department of Cardiology, Shenzhen People's Hospital, Shenzhen 518020, Guangdong, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tangzhiming Li
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tangzhiming Li, PhD.
Phone
+86 18588269277
Email
litangzhiming@126.com
First Name & Middle Initial & Last Name & Degree
Shaohong Dong, PhD.
Phone
+86 13509633742
Email
119538892@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
36017088
Citation
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.
Results Reference
derived
Learn more about this trial
Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
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