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Coronary Artery DiseaseNCT06791031

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

A study testing PCSK9 inhibitor (PCSK9i) in people with Coronary Artery Disease, run by West China Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PCSK9 inhibitor (PCSK9i)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
No sites listed yet
Study dates
Jan 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yong He contact

18980602038

heyongmd@wchscu.cn

Zhongxiu Chen contact

18030708238

czxlfb1988@163.com

About this study

Official title: 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.

Being tested
PCSK9 inhibitor (PCSK9i)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCSK9 inhibitor (PCSK9i)Drug

    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.

Study groups in NCT06791031
Study groupRoleWhat they receive
"PCSK9i early" intensified therapy groupExperimentalInitial addition of PCSK9i to moderate-intensity statin
Receives: Drug: PCSK9 inhibitor (PCSK9i)
Guideline-directed medical therapy groupNo interventionStepwise 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 6 months post randomization

Secondary outcomes (15)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At 6 months post randomization

  7. Change in total cholesterol

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

    Measured: At 3 months and 6 months post randomization

  8. Change in apolipoprotein B

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

    Measured: At 3 months and 6 months post randomization

  9. Change in lipoprotein(a)

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

    Measured: At 3 months and 6 months post randomization

  10. Change in triglycerides

    Change in triglycerides from baseline to 3 and 6 months.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At 3 months and 6 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06791031
Sponsor's protocol ID
WestChinaH-CVD-009
Status last verified
Nov 2024
First submitted
11 Jan 2025
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.

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

Questions about this trial

What is this clinical trial studying?

A study testing PCSK9 inhibitor (PCSK9i) in people with Coronary Artery Disease, run by West China Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yong He (18980602038, heyongmd@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in the minimum fibrous cap thickness of target lesions (time frame: At 6 months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06791031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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