Clinical trial NCT06416813: Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques
Official title: Preventive Intervention Value of Drug-Coated Balloons in Vulnerable Coronary Atherosclerotic Plaques
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Minimum luminal area
timeFrame: 1 year
Secondary outcomes:
measure: proportion of patients with vulnerable plaques in the target vessel
timeFrame: 1 year
measure: fibrous cap thickness
timeFrame: 1 year
measure: lipid core arc
timeFrame: 1 year
measure: Changes in LDL-C
timeFrame: 1 year
Other outcomes:
measure: Target vessel failure
timeFrame: 1 year
Locations:
Study officials:
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