Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques

NCT ID: NCT06416813

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-06
• Study Completion Date: 2027-12-01

Brief 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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GDMT

Group Type: NO_INTERVENTION

No interventions assigned to this group

GDMT+DCB

Group Type: EXPERIMENTAL

GDMT+DCB

Intervention Type: PROCEDURE

Preventive Intervention on Eligible Vulnerable Plaques Using DCB

Interventions

GDMT+DCB

Preventive Intervention on Eligible Vulnerable Plaques Using DCB

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years Diagnosis of ACS with the intention to undergo ICA There exists a nonculprit lesion characterized by a single diameter stenosis greater than 50% in the major coronary artery segments (with diameters ranging from 2.75 to 4 mm).

QFR value > 0.8 The OCT examination suggests vulnerable plaques with a fibrous cap thickness of < 65 µm, along with at least two of the other three OCT criteria Minimum lumen area <3.5 mm² Lipid core angle >180° Presence of macrophages lesion length ≤30 mm Provide informed consent Life expectancy greater than 1 year

Exclusion Criteria

Patients with three or more target lesions or with two target lesions in the same coronary artery left main stem lesions Ostial lesions Thrombotic lesions Severe calcification or angulated lesions True bifurcation lesions requiring stent implantation Advanced heart failure (NYHA III-IV) Ischemic stroke in the past 6 months or any history of cerebral hemorrhage at any time Severe valve disease or valve disease that may require surgical or percutaneous valve replacement Coronary artery anatomy obstructs the complete imaging of the segment of interest (including at least 5 mm beyond the narrow ends).

Diffuse coronary artery disease or the presence of ≥1 untreated nonculprit lesion (nonculprit blood flow-restricting lesion planned for staged PCI).

History of myocardial infarction, CABG, or PCI Coronary artery anatomy not suitable for PCI The potential comorbidity that may impact the completion of the trial process. The planned major surgery requires discontinuation of DAPT. History of PCSK9 inhibitor (such as evolocumab or alirocumab) use within 90 days prior to the first study visit.

Exposed to Inclisiran or any other non-PCSK9 monoclonal antibody targeted treatment within the 2 years preceding the initial study visit, whether as an investigational drug or a marketed medication.

History of allergy to the investigational drug, its excipients, or other siRNA drugs Females of childbearing potential, defined as all female subjects physiologically capable of becoming pregnant, unless they are using effective contraception during the administration of the investigational drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yong He

OTHER

Sponsor Role: lead

Responsible Party

Yong He

Head of Cardiology, Professor, Chief Physician, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

West China Hospital of Sichuan University

Sichuan Chengdu, Sichuan, China

Countries

China

Other Identifiers

WestChinaH-CVD-005

Identifier Type: -

Identifier Source: org_study_id