Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Sponsor
Shanghai Tong Ren Hospital
Study ID
NCT04731155
Phase
PHASE4
Status
Recruiting

Conditions

  • Early PCSK9 Inhibitor on Ventricular Remodling

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.

Key Dates

Start date
Apr 12, 2021
Status verified
May 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

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

Arms

  • Active Comparator: standard group
  • Experimental: experiment group

Primary Outcome Measure

myocardial salvage index measured by MRI [ Time Frame: one week after PPCI ]

Central Contacts