Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520904
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography in Patients With Premature Coronary Artery Disease a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease CAD However the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD evaluated through optical coherence tomography OCT remains inadequately understood Moreover there is a notable absence of relevant randomized controlled trials investigating this phenomenon This current study represents a single-center randomized controlled open-label trial conducted among Asian patients with early-onset CAD Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT
Detailed Description:
Following initial percutaneous coronary intervention PCI for culprit lesions in patients with early-onset coronary artery disease CAD and 2 additional lesions meeting baseline lipid criteria optical coherence tomography OCT was employed to evaluate non-culprit lesion sites for detailed characterization of plaque features including calcification fibrosis fibrolipid deposition necrosis minimum fibrous cap thickness mFCT and maximum lipid arc MLA Subsequently patients were randomized in a 11 ratio to receive either intensive statin therapy alone or a combination of PCSK9 inhibitor with moderate-intensity statin therapy using a random number allocation method After 1 year of treatment and follow-up OCT reassessment of non-culprit vessel critical lesions was conducted documenting plaque characteristics such as calcification fibrosis fibrolipid content necrosis as well as stability parameters like mFCT and MLA at lesion sites OCT findings were compared longitudinally within each treatment group and between groups receiving PCSK9 inhibitor combined with statin therapy versus intensive statin therapy alone Baseline clinical profiles biochemical markers imaging findings and incidence of adverse cardiovascular events during the follow-up period were also meticulously recorded for all enrolled early-onset CAD patients
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