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

Acute Coronary Syndrome Clinical Trial

Official title:

Preventive Intervention Value of Inclisiran Combined With Drug-Coated Balloons in Vulnerable Coronary Atherosclerotic Plaques

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416813
• Other study ID #: WestChinaH-CVD-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Plaque, Atherosclerotic

Intervention

Procedure:
• GDMT+DCB
Preventive Intervention on Eligible Vulnerable Plaques Using DCB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yong He

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Target vessel failure	A composite endpoint event encompassing cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization.	1 year
Primary	Minimum luminal area	Minimum luminal cross-sectional area of the target lesion measured 1 year after randomization.	1 year
Secondary	proportion of patients with vulnerable plaques in the target vessel	proportion of patients with vulnerable plaques in the target vessel	1 year
Secondary	fibrous cap thickness	Fibrous cap thickness	1 year
Secondary	lipid core arc	The lipid core arc as visualized on optical coherence tomography (OCT) refers to the angular extent and characteristics of the lipid-rich region within an atherosclerotic plaque. On cross-sectional OCT imaging, the lipid core appears as an area with high backscattering and high signal attenuation, distinguishing it from the surrounding fibrous or calcified plaque components. The key features of the lipid core arc include the arc angle (the angular extent of the lipid core in degrees), the arc thickness (the maximal radial thickness of the lipid core), and the arc location (the position of the lipid core relative to the lumen and other plaque components).	1 year
Secondary	Changes in LDL-C	The degree of changes in patients' LDL-C (low-density lipoprotein cholesterol) levels before and after treatment	1 year