A Phase 4 interventional study of Inclisiran in Carotid Plaque, Hyperlipidemia and Echocardiography, sponsored by First Affiliated Hospital of Xinjiang Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by First Affiliated Hospital of Xinjiang Medical University · Phase 4, Interventional, and Treatment
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.
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\'s effects over time, encompassing both biochemical and imaging parameters, while tracking potential adverse events.
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's planned enrollment of 40 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →First Affiliated Hospital of Xinjiang Medical University is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with carotid plaques undergoing treatment with inclisiran
Drug: Inclisiran
Patients with carotid plaques undergoing treatment with inclisiran
CIMT
Carotid artery intima media thickness
Time frame: Immediately and treated with inclisiran one year later
TMPT
The maximal plaque thickness
Time frame: Immediately and treated with inclisiran one year later
CPA
Carotid plaque area
Time frame: Immediately and treated with inclisiran one year later
CPV
Carotid plaque volume
Time frame: Immediately and treated with inclisiran one year later
CALA
Carotid artery lumen area
Time frame: Immediately and treated with inclisiran one year later
No study locations are listed for this record.
Plan to share: No — IPD will be made available on reasonable request to the official agencies.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Xinjiang Medical University