Preventive Intervention Value of Inclisiran Combined With DCB in Vulnerable Coronary Atherosclerotic Plaques - Trial NCT06416813
Access comprehensive clinical trial information for NCT06416813 through Pure Global AI's free database. This phase not specified trial is sponsored by Yong He and is currently Not yet recruiting. The study focuses on Acute Coronary Syndrome. Target enrollment is 140 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Yong He
West China Hospital
Timeline & Enrollment
N/A
Jun 01, 2024
Dec 01, 2027
Primary Outcome
Minimum luminal area
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06416813
Non-Device Trial