Clinical trial NCT06586684: Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
Official title: The Effect of Small Interfering RNA Inclisiran on Carotid Plaques in Patients with Atherosclerosis: a Real-world Study Using Carotid Ultrasound.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Carotid Plaque
Hyperlipidemia
Echocardiography
Keywords: inclisiran
carotid plaque
Echocardiography
hyperlipidmia
Lead sponsor: First Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Current understanding suggests that the majority of cardiovascular events are driven by vulnerable plaques. Nonetheless, the impact of PCSK9 inhibitors on the stability of carotid plaques remains insufficiently elucidated, with a notable scarcity of relevant clinical studies. This investigation seeks to address this gap through a real-world study conducted among patients with arterial sclerosis in Asia. The primary aim is to evaluate the effects of small interfering RNA (inclisiran) on carotid plaque characteristics as assessed by ultrasound, thereby contributing valuable data to inform clinical practice.

Detailed description: In a meticulous study evaluating the impact of inclisiran on patients with atherosclerosis and carotid plaques, data were systematically gathered across multiple time points. The assessment encompassed:Blood Samples: Analyzed at baseline (Month 0) and subsequently at Months 1, 2, 3, 5, 9, 11, and 12, examining biochemical markers, lipid profiles, and liver and kidney function tests.Carotid Ultrasound: Conducted at Months 0, 3, 9, and 12, monitoring the carotid intima-media thickness, maximum carotid plaque thickness, carotid plaque area, carotid plaque volume, and carotid lumen stenosis area for thorough analysis.Clinical Records: Documented in detail the baseline clinical information, biochemical markers, imaging findings, and any adverse cardiovascular or cerebrovascular events that occurred throughout the study period. This approach ensures a comprehensive understanding of inclisiran\&#39;s effects over time, encompassing both biochemical and imaging parameters, while tracking potential adverse events.

Eligibility criteria: Inclusion Criteria:

* Patients with carotid plaques as indicated by ultrasound
* Men and women aged 18-75 years;
* LDL-C \&gt;3.4 mmol/L without regular statin therapy or LDL-C \&gt;1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.

Exclusion Criteria:

* - Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
* Prior use of PCSK9 inhibitors;
* Prior history of hemorrhagic stroke;
* Prior coronary artery bypass grafting or coronary intervention;
* Inability to perform OCT imaging or unclear imaging;
* Severe renal insufficiency (creatinine clearance \&lt; 30 mL/min);
* Severe hepatic dysfunction;
* Baseline triglycerides \&gt; 5.6 mmol/L;
* Pregnant or lactating women;
* Life expectancy not exceeding 1 year;
* In the judgment of the investigator, unsuitable for this study for any reason.

Primary outcomes:
measure: CIMT
timeFrame: Immediately and treated with inclisiran one year later
measure: TMPT
timeFrame: Immediately and treated with inclisiran one year later
measure: CPA
timeFrame: Immediately and treated with inclisiran one year later
measure: CPV
timeFrame: Immediately and treated with inclisiran one year later
measure: CALA
timeFrame: Immediately and treated with inclisiran one year later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Zhenyan Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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