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Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
alirocumab
conventional treatment
Sponsored by
Shanghai Tong Ren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The age is greater than 18 years old and less than or equal to 80 years old.
  2. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
  3. Signed informed consent.

Exclusion Criteria:

  1. Patients who are allergic to PCSK9 inhibitors.
  2. Multivessel disease planned for selective intervention within half a year.
  3. Patients who have previously undergone revascularization.
  4. Pregnant women or women who plan to become pregnant in the next 2 years.
  5. Patients whose life expectancy is less than 1 year.
  6. Severe liver or kidney dysfunction (ALT>5 times ULA, eGFR<15ml/min/1.73m2)
  7. Known active malignant tumor diseases.
  8. Patients considered by the investigator to be unsuitable to participate in this study.

Sites / Locations

  • nineth people's hospital, School of Medicine, shanghai jiaotong universityRecruiting
  • Shanghai chest hospitalRecruiting
  • Shanghai tongren hospitalRecruiting
  • tenth people's hospital, tongji university, ShanghaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early PCSK9 inhibitor treatment group

conventional treatment group

Arm Description

Outcomes

Primary Outcome Measures

myocardial salvage index
measured by Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

Eject fraction
measured by MRI

Full Information

First Posted
March 13, 2022
Last Updated
October 31, 2022
Sponsor
Shanghai Tong Ren Hospital
Collaborators
China Cardiovascular Association
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1. Study Identification

Unique Protocol Identification Number
NCT05292404
Brief Title
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
Official Title
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Tong Ren Hospital
Collaborators
China Cardiovascular Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early PCSK9 inhibitor treatment group
Arm Type
Experimental
Arm Title
conventional treatment group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
alirocumab
Intervention Description
In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab,75mg) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
conventional treatment were given according to international uniformguidelines
Primary Outcome Measure Information:
Title
myocardial salvage index
Description
measured by Magnetic Resonance Imaging (MRI)
Time Frame
1 week after operation
Secondary Outcome Measure Information:
Title
Eject fraction
Description
measured by MRI
Time Frame
at 6 months after operation

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: The age is greater than 18 years old and less than or equal to 80 years old. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI . Signed informed consent. Exclusion Criteria: Patients who are allergic to PCSK9 inhibitors. Multivessel disease planned for selective intervention within half a year. Patients who have previously undergone revascularization. Pregnant women or women who plan to become pregnant in the next 2 years. Patients whose life expectancy is less than 1 year. Severe liver or kidney dysfunction (ALT>5 times ULA, eGFR<15ml/min/1.73m2) Known active malignant tumor diseases. Patients considered by the investigator to be unsuitable to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Hou, doctor
Phone
86-13564868096
Email
Dr_houlei@163.com
Facility Information:
Facility Name
nineth people's hospital, School of Medicine, shanghai jiaotong university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junfeng Zhang, doctor
Facility Name
Shanghai chest hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhenchi sang, doctor
Facility Name
Shanghai tongren hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Hou, doctor
Email
Dr_houlei@163.com
First Name & Middle Initial & Last Name & Degree
Lei Hou, doctor
Facility Name
tenth people's hospital, tongji university, Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhang, doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
36211588
Citation
Xia J, Wang X, Zhou J, Wang D, Pang Y, Xu X, Sang Z, Zhang Y, Zhang J, Wu S, Xiao Z, Hou L. Impact of early PCSK9 inhibitor treatment on heart after percutaneous coronary intervention in patients with STEMI: Design and rationale of the PERFECT II trial. Front Cardiovasc Med. 2022 Sep 23;9:1009674. doi: 10.3389/fcvm.2022.1009674. eCollection 2022.
Results Reference
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Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

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