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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Tong Ren Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • alirocumab
  • conventional treatment

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Tong Ren Hospital

Lead sponsor

China Cardiovascular Association

Collaborator