Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649240
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke SVO70
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SVO70
Brief Summary:
Lipid-lowering therapy constitutes a cornerstone of secondary prevention in ischemic stroke however current stroke guidelines remain deficient in providing optimal target low-density lipoprotein LDL-cholesterol levels tailored to the stroke subtypes Most clinical trials on LDL-cholesterol management have not differentiated between stroke subtypes or have primarily focused on large artery atherosclerosis LAA stroke leaving a gap in evidence for managing LDL-cholesterol in other stroke subtypes eg small vessel occlusion SVO stroke While hypertension is the leading risk factor for SVO strokes the link between elevated LDL-cholesterol and SVO stroke is also recognized Establishing optimal LDL-cholesterol targets for SVO stroke would significantly enhance secondary prevention strategies and improve patient outcome Thus the investigators aim to compare intensive versus standard lipid-lowering in patients with SVO stroke SVO70 is a multicenter prospective randomized open blinded-endpoint clinical trial Adult participants with objectively confirmed SVO stroke within 180 days of randomization will be included Exclusion criteria include those with predefined LDL-cholesterol targets for other conditions statin contraindications or women who are pregnant breastfeeding or planning pregnancy during the study period Eligible participants will be randomized 11 to target LDL-cholesterol 70 mgdL intensive group or 90-110 mgdL standard group The trial plans to enroll 4016 participants with the primary outcome being major adverse cardiovascular events-cardiovascular death stroke and acute coronary syndrome-during a follow-up period of at least 4 years This study would provide valuable information for determining the optimal LDL-cholesterol target for patients with SVO stroke
Detailed Description:
None
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