Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062832) titled 'Individualized Maintenance Lipid-Lowering Strategies After Initial Intensive PCSK9 Inhibition in Patients With Acute Myocardial Infarction: A Prospective Multicenter Serial Coronary CT Angiography Study' on Sept. 6.

Study Type: Observational

Primary Sponsor: Institute - Iwate Medical University

Condition: Condition - Acute myocardial infarction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare changes in whole-coronary noncalcified plaque volume (NCPV) from landmark CCTA to follow-up CCTA approximately 12 months later between two maintenance lipid-lowering strategies in patients who initiated PCSK9 inhibitor therapy within 90 days after acute myocardial infarction and continued it for at least 9 months: Strategy A, continuation of PCSK9 inhibitor therapy, and Strategy B, discontinuation of PCSK9 inhibitor therapy with goal-directed intensive oral lipid-lowering therapy targeting LDL-C <55 mg/dL. The study will also evaluate pFAI, CT-FFR, lipid biomarkers, 5-year clinical outcomes, and the feasibility of maintaining LDL-C <55 mg/dL without PCSK9 inhibitor reinitiation in Strategy B. Basic objectives2 - Others

Eligibility: Age-lower limit - 19 years-old <= Age-upper limit - Not applicable Gender - Male Key inclusion criteria - 1.Age grater than 18 years at landmark. 2.Index STEMI or NSTEMI treated with PCI of the culprit lesion. 3.At least one 50-90 persent diameter stenosis in a nonculprit coronary lesion at index AMI that was deferred from revascularization in routine clinical care. 4.PCSK9 inhibitor initiated within 90 days after index AMI and continued for at least 9 months before landmark. 5.Landmark scheduled 12 months after index AMI, with landmark CCTA performed or planned as part of routine clinical care. 6.Follow-up CCTA expected to be clinically performed 12 months after landmark CCTA. 7.Major clinical information from index AMI to landmark is available. 8.Receiving lipid-lowering therapy based on a maximally tolerated statin at landmark. 9.Strategy A or Strategy B targeting LDL-C less than 55 mg/dL is selected in routine clinical care. 10.Written informed consent obtained. Key exclusion criteria - 1.Planned staged PCI or CABG for the target nonculprit lesion. 2.Untreated significant left main coronary stenosis (diameter stenosis greater than 50%). 3.Previous CABG. 4.Contrast-enhanced CCTA considered inappropriate in routine clinical care, including eGFR less than 30 mL/min/1.73 m2 or acute kidney injury, history of severe iodinated contrast hypersensitivity/anaphylaxis, pregnancy or possible pregnancy, or other medical reasons. 5.Insufficient information regarding the index AMI, PCSK9 inhibitor exposure, or nonculprit lesions before landmark. 6.Unable to classify clearly as Strategy A or Strategy B at landmark. 7.Unable to provide written informed consent. 8.Considered inappropriate for enrollment by the investigator. Target Size - 362

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 06 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2033 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071925

Disclaimer: Curated by HT Syndication.