## Protocol Section
### Identification Module
**NCT ID:** NCT06416813

**Brief Title:** Preventive Intervention Value of Inclisiran Combined With DCB in Vulnerable Coronary Atherosclerotic Plaques

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

#### Organization Study ID Info
**ID:** WestChinaH-CVD-005
#### Organization
**Class:** OTHER
**Full Name:** West China Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yong He

#### Responsible Party

**Investigator Affiliation:** West China Hospital

**Investigator Full Name:** Yong He

**Investigator Title:** Head of Cardiology, Professor, Chief Physician, Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Acute Coronary Syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** GDMT

**Type:** NO_INTERVENTION

#### Arm Group 2

**Intervention Names:**

- Procedure: GDMT+DCB

**Label:** GDMT+DCB

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GDMT+DCB

**Description:** Preventive Intervention on Eligible Vulnerable Plaques Using DCB

**Name:** GDMT+DCB

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** A composite endpoint event encompassing cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization.

**Measure:** Target vessel failure

**Time Frame:** 1 year

#### Primary Outcomes

**Description:** Minimum luminal cross-sectional area of the target lesion measured 1 year after randomization.

**Measure:** Minimum luminal area

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** proportion of patients with vulnerable plaques in the target vessel

**Measure:** proportion of patients with vulnerable plaques in the target vessel

**Time Frame:** 1 year

**Description:** Fibrous cap thickness

**Measure:** fibrous cap thickness

**Time Frame:** 1 year

**Description:** 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).

**Measure:** lipid core arc

**Time Frame:** 1 year

**Description:** The degree of changes in patients' LDL-C (low-density lipoprotein cholesterol) levels before and after treatment

**Measure:** Changes in LDL-C

**Time Frame:** 1 year

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M29003

- Name: Plaque, Atherosclerotic

- Relevance: HIGH

- As Found: Atherosclerotic Plaque

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000054058

- Term: Acute Coronary Syndrome

- ID: D000058226

- Term: Plaque, Atherosclerotic

### Misc Info Module

- Version Holder: 2024-05-31
