Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586684
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Small Interfering RNA Inclisiran on Carotid Plaques in Patients with Atherosclerosis a Real-world Study Using Carotid Ultrasound
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 encompassedBlood 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 testsCarotid 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 analysisClinical 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 inclisiran39s effects over time encompassing both biochemical and imaging parameters while tracking potential adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None