Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques
StatusActive, Not Recruiting
PhaseNot applicable
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 Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
2024-07-27
Amendment Study Identification, Study Status v1
2024-05-10
Original filing
| 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 |