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Not yet recruitingNCT06791031Updated Nov 28, 2025

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

An interventional study of PCSK9 inhibitor (PCSK9i) in Coronary Artery Disease, sponsored by West China Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by West China Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 212 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
212 participants (estimated)

Study arms

  • Experimental
    "PCSK9i early" intensified therapy group

    Initial addition of PCSK9i to moderate-intensity statin

    Drug: PCSK9 inhibitor (PCSK9i)

  • 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.

Interventions

  • DrugPCSK9 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.

06

What researchers measure

Primary outcomes

  1. Absolute change in the minimum fibrous cap thickness of target lesions

    Absolute change in the minimum fibrous cap thickness of target lesions from baseline to 6 months.

    Time frame: At 6 months post randomization

Secondary outcomes

  1. Percent change in minimum fibrous cap thickness of target vessels

    Percent change in minimum fibrous cap thickness of target vessels from baseline to 6 months.

    Time frame: At 6 months post randomization

  2. Absolute change in mean minimum fibrous cap thickness across target vessels

    Absolute change in mean minimum fibrous cap thickness across target vessels from baseline to 6 months.

    Time frame: At 6 months post randomization

  3. Absolute changes in minimum lumen area of target vessels

    Absolute changes in minimum lumen area of target vessels from baseline to 6 months.

    Time frame: At 6 months post randomization

  4. Absolute changes in maximum lipid arc of target vessels

    Absolute changes in maximum lipid arc of target vessels from baseline to 6 months.

    Time frame: At 6 months post randomization

  5. Presence of macrophage infiltration in target vessels

    Presence of macrophage infiltration in target vessels from baseline to 6 months.

    Time frame: At 6 months post randomization

  6. Proportion of patients with OCT-identified vulnerable plaques

    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.

    Time frame: At 6 months post randomization

  7. Change in total cholesterol

    Change in total cholesterol from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  8. Change in apolipoprotein B

    Change in apolipoprotein B from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  9. Change in lipoprotein(a)

    Change in lipoprotein(a) from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  10. Change in triglycerides

    Change in triglycerides from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  11. Change in very low-density lipoprotein cholesterol

    Change in very low-density lipoprotein cholesterol from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  12. Change in low-density lipoprotein cholesterol

    Change in low-density lipoprotein cholesterol from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  13. Change in high-density lipoprotein cholesterol

    Change in high-density lipoprotein cholesterol from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  14. Proportion of patients achieving predefined LDL-C targets

    Proportion of patients achieving predefined LDL-C targets (\< 1.4 mmol/L) from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  15. Adherence to lipid-lowering therapy

    Adherence (proportion of days covered) to lipid-lowering therapy (statin, cholesterol absorption inhibitor, and PCSK9i) from baseline to 3 months and 6 months.

    Time frame: At 3 months and 6 months post randomization

Other outcomes

  1. Incidence of major adverse cardiovascular events (MACEs)

    MACEs are defined as the composite of cardiac death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization.

    Time frame: At 6 months and 12 months post randomization

  2. Incidence of bleeding events

    Bleeding events are defined according to the Academic Research Consortium (ARC) criteria.

    Time frame: At 6 months and 12 months post randomization

  3. Change in high-sensitivity C-reactive protein

    Change in high-sensitivity C-reactive protein from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  4. Change in Interleukin-6 (IL-6)

    Change in IL-6 levels from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  5. Change in tumor necrosis factor-alpha (TNF-α)

    Change in TNF-α levels from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  6. Change in absolute T-cell count

    Change in absolute T-cell count from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  7. Change in absolute B-cell count

    Change in absolute B-cell count from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

  8. Change in absolute natural killer (NK) cell count

    Change in absolute NK cell count from baseline to 3 and 6 months.

    Time frame: At 3 months and 6 months post randomization

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Chen Z, Ma S, Zhang J, Zhang R, Zhou M, Li C, Chen Y, Wang H, He Y; REPRESS trial investigator. PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in acute coronary syndromes (REPRESS): study protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Mar 18;16(3):e112947. doi: 10.1136/bmjopen-2025-112947. PubMed 41857839 ↗

Individual participant data

Plan to share: Yes — IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06791031
Lead sponsor
West China Hospital
Responsible party
Yong He (Professor, Sichuan University) — Principal investigator
First posted
Jan 24, 2025
Start date
Jan 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Nov 28, 2025

Study contacts

Yong He
Contact
heyongmd@wchscu.cn
18980602038
Zhongxiu Chen
Contact
czxlfb1988@163.com
18030708238
Yong He
principal investigator · Department of Cardiology, West China Hospital of Sichuan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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