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

Sponsor
Shanghai Tong Ren Hospital
Study ID
NCT05292404
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • alirocumab — DRUG
    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 — OTHER
    conventional treatment were given according to international uniformguidelines

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early PCSK9 inhibitor treatment group
  • Other: conventional treatment group

Primary Outcome Measure

myocardial salvage index [ Time Frame: 1 week after operation ]

Central Contacts

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