Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02588235
Status:
UNKNOWN
Last Update Posted:
2015-10-27
First Post:
2015-10-26
Brief Title:
Ezetimibe and Atorvastatin Therapy on TCFA
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Impact of Combined Ezetimibe and Atorvastatin Therapy on Coronary Thin-cap Fibroatheroma As Assessed by Optical Coherence Tomography
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After successful coronary angiography and OCT examination patients with TCFAs in non-culprit mild-to-moderate stenotic lesions will be enrolled Then they will be randomly assigned in a 11 ratio to receive either atorvastatin 20 mgday alone or atorvastatin 20 mgdayplus ezetimibe10 mgdayby envelope method Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months
Detailed Description:
This is a prospective randomized controlled open-label single-center study to evaluate the effect of ezetimibe added to atorvastatin on coronary thin-cap fibroatheromaTCFA After successful coronary angiography and OCT examination patients with TCFAs in non-culprit mild-to-moderate stenotic lesions will be enrolled Then they will be randomly assigned in a 11 ratio to receive either atorvastatin 20 mgday alone or atorvastatin 20 mgdayplus ezetimibe10 mgdayby envelope method
Angiographic and OCT follow-up will be scheduled for the target vessel after 12 monthsThe primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-upThe secondary endpoints include absolute and percent changes in the lipid glycemic and inflammatory profile Then changes of these indicators above will be compared respectively in diabetic and non-diabetic patients
Angiographic and OCT follow-up will be scheduled for the target vessel after 12 monthsThe primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-upThe secondary endpoints include absolute and percent changes in the lipid glycemic and inflammatory profile Then changes of these indicators above will be compared respectively in diabetic and non-diabetic 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