Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
1 other identifier
interventional
160
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2022
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 27, 2026
December 1, 2025
3.7 years
March 13, 2022
January 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
myocardial salvage index
measured by Magnetic Resonance Imaging (MRI)
1 week after operation
Secondary Outcomes (1)
Eject fraction
at 6 months after operation
Study Arms (2)
Early PCSK9 inhibitor treatment group
EXPERIMENTALconventional treatment group
OTHERInterventions
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
conventional treatment were given according to international uniformguidelines
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Tong Ren Hospitallead
- China Cardiovascular Associationcollaborator
Study Sites (5)
nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai, Shanghai Municipality, 200050, China
Shanghai chest hospital
Shanghai, Shanghai Municipality, 200050, China
Shanghai tongren hospital
Shanghai, Shanghai Municipality, 200050, China
tenth people's hospital, tongji university, Shanghai
Shanghai, Shanghai Municipality, 200050, China
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Related Publications (1)
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.
PMID: 36211588DERIVED
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 13, 2022
First Posted
March 23, 2022
Study Start
October 1, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 27, 2026
Record last verified: 2025-12