PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Synd… (NCT06791031) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS)
212 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Absolute change in the minimum fibrous cap thickness of target lesions