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

NCT ID: NCT06791031

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-06-30

Brief 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

"PCSK9i early" intensified therapy group

Initial addition of PCSK9i to moderate-intensity statin

Group Type: EXPERIMENTAL

PCSK9 inhibitor (PCSK9i)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong He

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, West China Hospital of Sichuan University

Central Contacts

Yong He

Role: CONTACT

heyongmd@wchscu.cn

18980602038

Zhongxiu Chen

Role: CONTACT

czxlfb1988@163.com

18030708238

Other Identifiers

WestChinaH-CVD-009

Identifier Type: -

Identifier Source: org_study_id