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Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques

StatusActive, Not Recruiting
PhaseNot applicable
SponsorYong He
Started2025-06-06
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 2 times since 2024-05-10; most recent filed 2025-08-30. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-08-30
Amendment Not Yet RecruitingActive, Not Recruiting Study Status, Contacts/Locations v2
2024-07-27
Amendment Study Identification, Study Status v1
2024-05-10
Original filing
Trial Details
NCT Number NCT06416813
Lead Sponsor Yong He
Conditions Acute Coronary Syndrome
Enrollment 140 participants
Start Date 2025-06-06
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-08