The PASSIVATE-CAP study is an investigator-initiated, prospective, randomized, multicenter, open-label superiority trial focusing on acute coronary syndrome (ACS) patients with nonflow-limiting vulnerable plaques in nonculprit vessels. In this study, eligible patients were randomized at a 1:1 ratio into two groups: patients who received guideline-directed medical therapy (GDMT) and patients who received GDMT combined with a drug-coated balloon (DCB). In this study, the use of PCSK9 inhibitors was limited to inclisiran. The primary endpoint was the minimal lumen area of the target lesion 1 year after randomization. The secondary endpoints encompass a range of factors, including the proportion of patients with vulnerable plaques in the target vessel, fibrous cap thickness, lipid core arc of the target lesion, minimal lumen area of the target vessel, and extent of LDL-C reduction in patients treated with inclisiran.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Preventive Intervention on Eligible Vulnerable Plaques Using DCB
West China Hospital of Sichuan University
Sichuan Chengdu, Sichuan, China
Minimum luminal area
Minimum luminal cross-sectional area of the target lesion measured 1 year after randomization.
Time frame: 1 year
proportion of patients with vulnerable plaques in the target vessel
proportion of patients with vulnerable plaques in the target vessel
Time frame: 1 year
fibrous cap thickness
Fibrous cap thickness
Time frame: 1 year
lipid core arc
The lipid core arc as visualized on optical coherence tomography (OCT) refers to the angular extent and characteristics of the lipid-rich region within an atherosclerotic plaque. On cross-sectional OCT imaging, the lipid core appears as an area with high backscattering and high signal attenuation, distinguishing it from the surrounding fibrous or calcified plaque components. The key features of the lipid core arc include the arc angle (the angular extent of the lipid core in degrees), the arc thickness (the maximal radial thickness of the lipid core), and the arc location (the position of the lipid core relative to the lumen and other plaque components).
Time frame: 1 year
Changes in LDL-C
The degree of changes in patients' LDL-C (low-density lipoprotein cholesterol) levels before and after treatment
Time frame: 1 year
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