Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604117
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-15
Brief Title:
Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open-label Study Evaluating the Effects of Probucol Combined with Statins on Atherosclerotic Characteristics and Prognosis in Patients with Ischemic Stroke
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:
EPCIS
Brief Summary:
The goal of this clinical trial is to evaluate whether the combination of Probucol with statin therapy can reduce the risk of vascular events and improve atherosclerosis outcomes in adults with ischemic stroke and confirmed atherosclerosis The main questions it aims to answer are
Does adding Probucol to statin therapy reduce plaque burden more effectively than statins alone Does the combination therapy lead to fewer cardiovascular and cerebrovascular events compared to statins alone Researchers will compare participants receiving standard statin therapy to those receiving statins combined with Probucol to assess differences in plaque burden and the occurrence of vascular events
Participants will
Choose either standard statin therapy with possible addition of ezetimibe or PCSK9 inhibitors or the same therapy combined with Probucol 05g twice daily
Attend regular follow-up visits for monitoring atherosclerosis features and cardiovascular health over a 3-year period
Undergo imaging studies to evaluate changes in atherosclerosis and blood tests to monitor lipid levels and other biomarkers
Does adding Probucol to statin therapy reduce plaque burden more effectively than statins alone Does the combination therapy lead to fewer cardiovascular and cerebrovascular events compared to statins alone Researchers will compare participants receiving standard statin therapy to those receiving statins combined with Probucol to assess differences in plaque burden and the occurrence of vascular events
Participants will
Choose either standard statin therapy with possible addition of ezetimibe or PCSK9 inhibitors or the same therapy combined with Probucol 05g twice daily
Attend regular follow-up visits for monitoring atherosclerosis features and cardiovascular health over a 3-year period
Undergo imaging studies to evaluate changes in atherosclerosis and blood tests to monitor lipid levels and other biomarkers
Detailed Description:
This single-center prospective open-label study will assess the effects of combining Probucol with statin therapy on the progression of atherosclerosis and the risk of vascular events in people with ischemic stroke The primary hypothesis is that in participants receiving guideline-recommended statin therapy the addition of Probucol will reduce cardiovascular and cerebrovascular event risk enhance plaque stability and be well-tolerated
The study will include participants aged 18 years or older who have experienced an ischemic stroke within the past 30 days and have confirmed atherosclerosis in any major artery carotid coronary aortic renal or peripheral arteries Participants will either follow a guideline-recommended lipid-lowering regimen statins with or without ezetimibe or PCSK9 inhibitors as needed or a similar regimen combined with Probucol 05g twice daily The study will enroll at least 100 participants in both the standard therapy group and the Probucol combination group
Primary outcomes will include changes in plaque burden while secondary outcomes will cover atherosclerotic features composite vascular events ischemic stroke ischemic heart disease vascular death stroke recurrence and poor functional prognosis mRS 3 Exploratory outcomes will include changes in biochemical markers such as LDL-C Ox-LDL and Lpa Safety will be assessed by monitoring adverse events and serious adverse events
Statistical analysis will include a multivariate linear regression model for primary outcomes adjusted for baseline characteristics such as LDL-C levels and previous cardiovascular events For time-to-event endpoints Kaplan-Meier curves will be used with Cox proportional hazards models providing hazard ratios Subgroup analyses and repeated measures will further refine the understanding of treatment effects
The study will include participants aged 18 years or older who have experienced an ischemic stroke within the past 30 days and have confirmed atherosclerosis in any major artery carotid coronary aortic renal or peripheral arteries Participants will either follow a guideline-recommended lipid-lowering regimen statins with or without ezetimibe or PCSK9 inhibitors as needed or a similar regimen combined with Probucol 05g twice daily The study will enroll at least 100 participants in both the standard therapy group and the Probucol combination group
Primary outcomes will include changes in plaque burden while secondary outcomes will cover atherosclerotic features composite vascular events ischemic stroke ischemic heart disease vascular death stroke recurrence and poor functional prognosis mRS 3 Exploratory outcomes will include changes in biochemical markers such as LDL-C Ox-LDL and Lpa Safety will be assessed by monitoring adverse events and serious adverse events
Statistical analysis will include a multivariate linear regression model for primary outcomes adjusted for baseline characteristics such as LDL-C levels and previous cardiovascular events For time-to-event endpoints Kaplan-Meier curves will be used with Cox proportional hazards models providing hazard ratios Subgroup analyses and repeated measures will further refine the understanding of treatment effects
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