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Observational Study on the Impact of Early Initiation of PCSK9 Inhibitors on Non-Culprit Lesions and Microcirculation in Acute Coronary Syndrome

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Acute Coronary Syndrome
Date of first enrollment	31/07/2025
Target sample size	150
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

In the group administered PCSK9 inhibitors at discharge and the non-administered group, intravascular ultrasound (IVUS) images obtained during follow-up catheterization at 6 months will be used to compare the change in plaque volume within the culprit vessel. The analysis will focus on segments where no therapeutic interventions (e.g., thrombus aspiration, balloon dilation, stent placement) were performed. Prospectively registered cases will be the primary focus, but retrospectively collected cases with analyzable images obtained under the same criteria will also be included.

Secondary Outcome

Changes in lipid parameters Evaluate changes from baseline in blood lipid levels, including LDL-C, HDL-C, and triglycerides (TG) As routine clinical test results are used, evaluation is feasible regardless of study site or registration type (prospective/retrospective). Presence of coronary revascularization Confirm whether PCI or CABG was performed after 6 months and compare the presence or absence of revascularization between groups. Evaluation will be based on medical records, test findings, and imaging data.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	Patients who have undergone percutaneous coronary intervention due to acute coronary syndrome, including unstable angina, ST-elevation myocardial infarction, or non-ST-elevation myocardial infarction. At the time of registration, patients must already be taking both statin and ezetimibe. In addition, patients must meet one of the following conditions regarding low-density lipoprotein cholesterol The LDL cholesterol level measured within seven days before discharge is more than fifty-five milligrams per deciliter. The LDL cholesterol level measured within thirty-five days before admission is more than fifty-five milligrams per deciliter. The LDL cholesterol level measured before discharge and prior to medication is more than one hundred thirty milligrams per deciliter. Patients must be eighteen years of age or older at the time of registration, and written informed consent must be obtained from the individual.
Exclude criteria	Patients who have already been treated with PCSK9 inhibitors prior to PCI. Patients scheduled to receive inclisiran sodium after discharge. Patients who will not undergo follow-up catheterization at the study site. Retrospective cases who expressed refusal to participate after public disclosure (cases from Jan 1, 2015 to the date of study approval). Patients deemed inappropriate for participation by the attending physician. Patients with missing essential clinical data (e.g., imaging or test results) that prevent analysis of primary endpoints.