Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period

NCT07290699 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IIT-I-2025-098
• Study Type: interventional
• Target: 2,442
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI); STEMI - ST Elevation Myocardial Infarction

Keywords

Acute myocardial infarction; Recaticimab; PCSK9 inhibitor

Outcome Measures

Primary Outcomes (1)

• MACE

  The primary endpoint was 1-year MACE (major adverse cardiovascular and cerebrovascular events, including cardiac death, non fatal myocardial infarction, non fatal stroke, or hospitalization due to unplanned unstable angina and coronary revascularization).

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (10)

• LDL-C reduction absolute value

  From enrollment to the end of treatment at 12 months, and record the values for every 1, 3, 6, 9, and 12 months if possible.

• LDL-C targets achieved rate

  From enrollment to the end of treatment at 12 months, and record the values for every 1, 3, 6, 9, and 12 months if possible

• Changes in Lp (a) levels

  From enrollment to the end of treatment at 12 months, and record the values for every 1, 3, 6, 9, and 12 months if possible

• Changes in the size of carotid plaques

  From baseline to the mid at 6 months and end of treatment at the 12 months

• Observation indicators of safety

  From enrollment to the end of treatment at 1, 3, 6, 9 ,12 months.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intensive lipid-lowering within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors)；Recaticimab 450 mg once every 12 weeks

Drug: Recaticimab

Control group

NO INTERVENTION

Standard treatment (antiplatelet drugs, 20mg atorvastatin / 10mg rosuvastatin ± cholesterol absorption inhibitors)

Interventions

Recaticimab DRUG

Recaticimab 450 mg once every 12 weeks. Group 1 (G1, experimental group): Intensive lipid-lowering therapy within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors), treatment for 6 months; Group 2 (G2, control group): standard treatment (antiplatelet drugs, 20 mg atorvastatin/10 mg rosuvastatin ± cholesterol absorption inhibitors). After 6 months, both groups continued with guideline-recommended conventional treatment.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe mental disorders that prevent the expression of consent;
• Severe heart failure (Killip class III or IV) or cardiogenic shock;
• 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;
• Investigator's judgment that the subject cannot complete long-term follow-up;
• Intolerance to statins or cholesterol absorption inhibitors;
• Intolerance to injections;
• Subjects who received PCSK9 inhibitor treatment or participated in other PCSK9 inhibitor studies within 4 months before randomization;
• Pregnant women.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• First Affiliated Hospital of Gannan Medical University: collaborator
• Jiujiang No.1 People's Hospital: collaborator
• First People's Hospital of FuZhou: collaborator
• Yueyang Central Hospital: collaborator
• The First People's Hospital of Changde City: collaborator
• ZhuZhou Central Hospital: collaborator
• Xiangtan Central Hospital: collaborator
• Loudi Central Hospital: collaborator

Related Publications (19)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Long Jiang, Ph.D.

CONTACT

+86-13767026990; skyiadx@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share