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NCT06416813Not yet recruiting

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

Preventive Intervention Value of Inclisiran Combined With Drug-Coated Balloons in Vulnerable Coronary Atherosclerotic Plaques
Yong HeClinicalTrials.govprocedure
Study focus
Drug/Device/Intervention
GDMT+DCB
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Yong He
Funder
West China Hospital
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Dec 01, 2027
Enrollment
140 participants
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
Acute myocardial infarctionAcute myocardial infarction, unspecifiedAcute subendocardial myocardial infarctionAcute ischaemic heart disease, unspecifiedOther acute ischaemic heart diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06416813
Type
Non-Device Trial
About this record

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.

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