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Preventive Intervention Value of Inclisiran Combined With DCB in Vulnerable Coronary Atherosclerotic Plaques

Acute Coronary Syndrome Clinical Trial

Official title:
Preventive Intervention Value of Inclisiran Combined With Drug-Coated Balloons in Vulnerable Coronary Atherosclerotic Plaques

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06416813
Study type Interventional
Source West China Hospital
Contact
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date December 1, 2027
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