Clinical trial NCT05292404: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
Collaborators: name: China Cardiovascular Association
First posted: 2022-03-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PCSK9 inhibitor
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: myocardial salvage index
timeFrame: 1 week after operation
Secondary outcomes:
measure: Eject fraction
timeFrame: at 6 months after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: nineth people's hospital, School of Medicine, shanghai jiaotong university
state: Shanghai
city: Shanghai
country: China
facility: Shanghai chest hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai tongren hospital
state: Shanghai
city: Shanghai
country: China
facility: tenth people's hospital, tongji university, Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
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.