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NCT07290699Not yet recruitingPhase 4

Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period

INtensive Cholesterol-Lowering With recatIcimab combiNation in Emergency PCI for Acute Myocardial Infarction: A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

This project team is conducting a multicenter randomized controlled study, aiming to administer PCSK9 inhibitors subcutaneously as early as possible within 24 hours during the perioperative period of AMI (included \<24h STEMI and NSTEMI), and subsequently once every 12 weeks for a total of 6 months, followed by step-down therapy according to guideline-recommended lipid-lowering strategies based on LDL-C target levels. The study will evaluate changes in blood lipids and inflammatory markers during hospitalization and at follow-up visits at 1, 3, 6, 9, and 12 months, as well as the incidence of MACE events. Safety will also be assessed, including liver enzymes, kidney function, and other adverse reactions. Compared with conventional treatment, the study will test efficacy and ultimately clarify that early combined use of PCSK9 inhibitors during the perioperative period of AMI patients can safely and effectively reduce LDL-C, control systemic inflammatory responses, and improve the incidence of MACE events.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2442 (estimated)
First submitted
16 Nov 2025
Start date
1 Jan 2026
Primary completion date
30 Aug 2027
Lead sponsor
Second Affiliated Hospital of Nanchang University
NCT number
NCT07290699

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 2442
  • From 1 Jan 2026 to the primary completion date, 30 Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intolerance to statins or cholesterol absorption inhibitors;
  • Subjects who received PCSK9 inhibitor treatment or participated in other PCSK9 inhibitor studies within 4 months before randomization;

Other illness

  • Severe mental disorders that prevent the expression of consent;
  • Severe heart failure (Killip class III or IV) or cardiogenic shock;

Lab values

  • According to the investigator's judgment, the presence of significant other abnormal signs, laboratory findings, or clinical conditions (such as tumors, shock, liver or kidney failure, etc.) that make participation unsuitable;

Other

  • Investigator's judgment that the subject cannot complete long-term follow-up;
  • Intolerance to injections;
  • Pregnant women.

Who the study is looking for

  • Age ≥18 years;
  • Meet the definition of acute myocardial infarction according to the "2019 Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction", including STEMI and NSTEMI with onset \<24 hours;
  • Able to understand and voluntarily sign the informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.