Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period (INCLINE-AMI)

December 16, 2025 updated by: Second Affiliated Hospital of Nanchang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, prospective, randomized controlled trial, with the Second Affiliated Hospital of Nanchang University as the leading center and 80 sub-centers established. The enrollment period is from September 1, 2025, to August 30, 2027, with a follow-up of 1 year. A total of 2,442 patients who meet the inclusion criteria will be randomly assigned to: Group 1 (G1, experimental group): intensive lipid-lowering therapy within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors) for 6 months; Group 2 (G2, control group): standard lipid-lowing treatment (20 mg atorvastatin/10 mg rosuvastatin ± cholesterol absorption inhibitors). After 6 months, both groups will continue treatment according to guideline-recommended standard therapy.

Randomization method: All eligible patients entering the respective groups will be randomly obtained a random number. The maximum follow-up period is 1 year. Safety evaluation includes monitoring all adverse events (AEs), serious adverse events (SAEs), as well as regular monitoring of vital signs and clinical laboratory tests.

Each center will screen hospitalized AMI patients according to inclusion and exclusion criteria. Baseline data will be entered into the CRF form for the first time, including basic patient information, admission details, laboratory and instrument examinations, surgical procedure details, postoperative medications, and occurrence of adverse events during hospitalization. After discharge, follow-up visits will be conducted at 1 month, 3 months, 6 months, 9 months, and 1 year, inquiring about current health status and medication usage, and recording the occurrence of endpoint events and lipid levels in the follow-up section of the CRF.

Study Type

Interventional

Enrollment (Estimated)

2442

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
No Intervention: Control group
Standard treatment (antiplatelet drugs, 20mg atorvastatin / 10mg rosuvastatin ± cholesterol absorption inhibitors)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: From enrollment to the end of treatment at 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-C reduction absolute value
Time Frame: 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 reduction absolute value means, it refers to the LDL-C value measured in the 12th month minus the LDL-C value measured at baseline.
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
Time Frame: 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, it refers to whether the LDL-C at the 12th month has reached the target value recommended by the guidelines for the patient.
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
Time Frame: 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, it refers to the changes in baseline Lp (a) levels and Lp (a) levels at the 12th month
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
Time Frame: From baseline to the mid at 6 months and end of treatment at the 12 months
Record changes in carotid plaque size at baseline and 12-month follow-up
From baseline to the mid at 6 months and end of treatment at the 12 months
Observation indicators of safety
Time Frame: From enrollment to the end of treatment at 1, 3, 6, 9 ,12 months.
Adverse events (AEs) are defined as any adverse medical events that occur during the period from the signing of informed consent by clinical trial subjects until the completion of the study.
From enrollment to the end of treatment at 1, 3, 6, 9 ,12 months.
The occurrence rate of MACE events in 6 months
Time Frame: From enrollment to the end of treatment at 6 months.
6-month incidence of MACE events (referring to cardiac death, non fatal myocardial infarction, hospitalization due to unstable angina, and coronary revascularization);
From enrollment to the end of treatment at 6 months.
Cardiac death
Time Frame: From enrollment to the end of treatment at 6 months and 1 year
Record cardiac death at 6 months and 1 year
From enrollment to the end of treatment at 6 months and 1 year
Non fatal myocardial infarction
Time Frame: From enrollment to the end of treatment at 6 months and 1 year.
Recard non fatal myocardial infarction at 6 months and 1 year.
From enrollment to the end of treatment at 6 months and 1 year.
Non fatal stroke
Time Frame: From enrollment to the end of treatment at 6 months and 1 year
Record non fatal stroke at 6 months and 1 year
From enrollment to the end of treatment at 6 months and 1 year
Hospitalization due to unplanned unstable angina and coronary revascularization
Time Frame: From enrollment to the end of treatment at 6 months and 1 year.
Record hospitalization due to unplanned unstable angina and coronary revascularization at 6 months and 1 year.
From enrollment to the end of treatment at 6 months and 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Collaborators

ZhuZhou Central Hospital
First Affiliated Hospital of Gannan Medical University
Jiujiang No.1 People's Hospital
Loudi Central Hospital
Xiangtan Central Hospital
Yueyang Central Hospital
The First People's Hospital of Changde City
First People's Hospital of FuZhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2028

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-I-2025-098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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