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
- PCSK9 inhibitor (Alirocumab)plus standard medications — DRUGPCSK9 inhibitor(Alirocumab) was giving to subjects before PPCI and continued twice a month until 3 month after AMI
- standard medications — DRUGstandard medications was giving to subjects according guidelines
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
- Lei Hou, Doctor13564868096