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Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction: a Muti-center, Open-label, Randomized Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
nineth people's hospital, School of Medicine, shanghai jiaotong university
RECRUITING
Shanghai
Shanghai chest hospital
RECRUITING
Shanghai
Shanghai tongren hospital
RECRUITING
Shanghai
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
tenth people's hospital, tongji university, Shanghai
RECRUITING
Shanghai
Contact Information
Primary
Lei Hou, doctor
Dr_houlei@163.com
86-13564868096
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 160
Treatments
Experimental: Early PCSK9 inhibitor treatment group
Other: conventional treatment group
Related Therapeutic Areas
Sponsors
Collaborators: China Cardiovascular Association
Leads: Shanghai Tong Ren Hospital

This content was sourced from clinicaltrials.gov

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