PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS)

November 21, 2025 updated by: Yong He, West China Hospital

PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS): Study Protocol for a Multicenter Randomized Controlled Trial

In this prospective, multicenter, open-label trial, 212 ACS patients will be randomized 1:1 to either the "PCSK9i early" intensified therapy group (initial addition of PCSK9i to moderate-intensity statin) or the guideline-directed medical therapy group for 6 months. Serial OCT imaging of non-culprit arteries (20-70% stenosis) is performed at baseline and 6 months. The primary endpoint is the absolute change in minimum fibrous cap thickness at 6 months, and secondary endpoints including changes in lumen area, lipid arc, macrophage infiltration, LDL-C reduction, and target LDL-C achievement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female, age ≥ 18 years at screening
  • Acute coronary syndrome who underwent PCI of the culprit lesions.
  • Non-culprit vessel (target vessel) meets the following criteria after culprit vessel PCI:
  • Target vessel diameter > 2.5 mm, suitable for OCT examination
  • Target vessel with angiographically estimated stenosis (diameter stenosis 20-70%)
  • Target vessel must be native coronary arteries, vessel segment without previous PCI
  • Target vessel cannot be a venous or arterial bridge vessel
  • Ability to cooperate the requirements of the study and to offer written informed consent
  • Willingness to complete follow-up visits and examinations as required by the schedule
  • Life expectancy > 1 year

Exclusion Criteria:

  • Left main disease of non-culprit artery, defined as ≥ 50% reduction in lumen diameter of the left main coronary artery via angiographic visual estimation
  • Thrombotic target lesion, severe calcification or tortuosity lesions unfavorable for OCT examination
  • Coronary artery anatomy that prevents complete imaging of the segment of interest (including at least 5 mm of both edges of the stenosis)
  • True bifurcation lesions requiring stenting
  • TIMI flow < 2 of the culprit-related arteries after PCI
  • Unstable clinical status (cardiogenic shock, hemodynamic or electrical instability)
  • Advanced heart failure (New York cardiac class III-IV)
  • Ischaemic stroke within the past 6 months or cerebral haemorrhage at any time in the past
  • Severe valvular disease or valvular disease that may require surgery or percutaneous valve replacement
  • Diffuse coronary artery lesions or the presence of ≥ 1 untreated non-culprit lesion (non-culprit flow-restricting lesion planned for near-term, phase II PCI)
  • Target vessel with coronary artery bypass grafting or PCI
  • Planned major surgery requiring interruption of dual-antiplatelet therapy
  • Statin intolerance and patients unsuitable for statin therapy with alanine aminotransferase greater than 3 times the upper limit of normal or creatine kinase greater than 3 times the upper limit of normal (not attribute to an acute MI) or greater
  • Familial hypercholesterolaemia
  • Prior (within 180 days prior to the first study visit) exposure to PCSK9i, either as an experimental or marketed drug
  • Female subjects of childbearing potential, defined as all female subjects who are physiologically capable of becoming pregnant, unless such female subjects are using an effective method of contraception during the trial
  • Women who are pregnant or breastfeeding or intend to become pregnant
  • Comorbidities with malignancies, active infections, or major hematologic, metabolic, or endocrine disorders are judged unsuitable by the investigator
  • Severe hepatic insufficiency (Child-Pugh class C)
  • Severe renal dysfunction (estimated glomerular filtration rate < 30 mL/min/1.73 m2)
  • Current enrollment in another investigational device or drug study
  • Poor adherence and unable to complete the expected follow-up

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: "PCSK9i early" intensified therapy group
Initial addition of PCSK9i to moderate-intensity statin
Drug: PCSK9 inhibitor (PCSK9i)
Patients randomized to the "PCSK9i early" intensified therapy group will receive initial treatment with a PCSK9 inhibitor-either evolocumab 140 mg or alirocumab 75 mg, both administered subcutaneously every two weeks with the initial dose given during hospitalization and subsequent doses self-administered at home-or inclisiran sodium 300 mg (equivalent to 284 mg inclisiran), administered by healthcare professionals at baseline and again at the 3-month study visit. All patients will receive moderate-intensity statin, including atorvastatin 20 mg or rosuvastatin 10 mg. The intervention will be initiated during hospitalization for the index ACS event, within 24 hours of randomization, irrespective of baseline LDL-C levels or prior statin use.
No Intervention: Guideline-directed medical therapy group
Stepwise lipid-lowering strategies based on the 2025 American College of Cardiology/American Heart Association guidelines for ACS, Chinese Lipid Management Guidelines (2023), and Expert Consensus on Clinical Pathways for Lipid Management in Chinese Patients with ACS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute change in the minimum fibrous cap thickness of target lesions
Time Frame: At 6 months post randomization
Absolute change in the minimum fibrous cap thickness of target lesions from baseline to 6 months.
At 6 months post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent change in minimum fibrous cap thickness of target vessels
Time Frame: At 6 months post randomization
Percent change in minimum fibrous cap thickness of target vessels from baseline to 6 months.
At 6 months post randomization
Absolute change in mean minimum fibrous cap thickness across target vessels
Time Frame: At 6 months post randomization
Absolute change in mean minimum fibrous cap thickness across target vessels from baseline to 6 months.
At 6 months post randomization
Absolute changes in minimum lumen area of target vessels
Time Frame: At 6 months post randomization
Absolute changes in minimum lumen area of target vessels from baseline to 6 months.
At 6 months post randomization
Absolute changes in maximum lipid arc of target vessels
Time Frame: At 6 months post randomization
Absolute changes in maximum lipid arc of target vessels from baseline to 6 months.
At 6 months post randomization
Presence of macrophage infiltration in target vessels
Time Frame: At 6 months post randomization
Presence of macrophage infiltration in target vessels from baseline to 6 months.
At 6 months post randomization
Proportion of patients with OCT-identified vulnerable plaques
Time Frame: At 6 months post randomization
Proportion of patients with OCT-identified vulnerable plaques (defined as FCT < 75 µm plus at least two of three features: lipid arc > 180°, MLA < 3.5 mm², and macrophage infiltration) from baseline to 6 months.
At 6 months post randomization
Change in total cholesterol
Time Frame: At 3 months and 6 months post randomization
Change in total cholesterol from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in apolipoprotein B
Time Frame: At 3 months and 6 months post randomization
Change in apolipoprotein B from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in lipoprotein(a)
Time Frame: At 3 months and 6 months post randomization
Change in lipoprotein(a) from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in triglycerides
Time Frame: At 3 months and 6 months post randomization
Change in triglycerides from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in very low-density lipoprotein cholesterol
Time Frame: At 3 months and 6 months post randomization
Change in very low-density lipoprotein cholesterol from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in low-density lipoprotein cholesterol
Time Frame: At 3 months and 6 months post randomization
Change in low-density lipoprotein cholesterol from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in high-density lipoprotein cholesterol
Time Frame: At 3 months and 6 months post randomization
Change in high-density lipoprotein cholesterol from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Proportion of patients achieving predefined LDL-C targets
Time Frame: At 3 months and 6 months post randomization
Proportion of patients achieving predefined LDL-C targets (< 1.4 mmol/L) from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Adherence to lipid-lowering therapy
Time Frame: At 3 months and 6 months post randomization
Adherence (proportion of days covered) to lipid-lowering therapy (statin, cholesterol absorption inhibitor, and PCSK9i) from baseline to 3 months and 6 months.
At 3 months and 6 months post randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of major adverse cardiovascular events (MACEs)
Time Frame: At 6 months and 12 months post randomization
MACEs are defined as the composite of cardiac death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization.
At 6 months and 12 months post randomization
Incidence of bleeding events
Time Frame: At 6 months and 12 months post randomization
Bleeding events are defined according to the Academic Research Consortium (ARC) criteria.
At 6 months and 12 months post randomization
Change in high-sensitivity C-reactive protein
Time Frame: At 3 months and 6 months post randomization
Change in high-sensitivity C-reactive protein from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in Interleukin-6 (IL-6)
Time Frame: At 3 months and 6 months post randomization
Change in IL-6 levels from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in tumor necrosis factor-alpha (TNF-α)
Time Frame: At 3 months and 6 months post randomization
Change in TNF-α levels from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in absolute T-cell count
Time Frame: At 3 months and 6 months post randomization
Change in absolute T-cell count from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in absolute B-cell count
Time Frame: At 3 months and 6 months post randomization
Change in absolute B-cell count from baseline to 3 and 6 months.
At 3 months and 6 months post randomization
Change in absolute natural killer (NK) cell count
Time Frame: At 3 months and 6 months post randomization
Change in absolute NK cell count from baseline to 3 and 6 months.
At 3 months and 6 months post randomization

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yong He, Department of Cardiology, West China Hospital of Sichuan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WestChinaH-CVD-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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