Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01946815
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2013-09-12
Brief Title:
Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease
Sponsor:
Keimyung University Dongsan Medical Center
Organization:
Keimyung University Dongsan Medical Center
Study Overview
Official Title:
Phase 3 Study of Effect of ATorvastatin on Fractional Flow Reserve in Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
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:
FORTE
Brief Summary:
Natural course of intermediate coronary artery disease CAD is very important to predict the prognosis of the patient with such disease
Several studies have well demonstrated the beneficial effect of lipid-lowering therapy on the progression of CAD with the modification of lipid profiles
This effect can be also explained by intravascular ultrasound IVUS or optical coherence tomography However the effect of plaque modification on coronary physiology has been rarely evaluated
This research is to evaluate the change of intermediate or nonculprit coronary lesion on lipid-lowering therapy via IVUSoptional and FFR
Several studies have well demonstrated the beneficial effect of lipid-lowering therapy on the progression of CAD with the modification of lipid profiles
This effect can be also explained by intravascular ultrasound IVUS or optical coherence tomography However the effect of plaque modification on coronary physiology has been rarely evaluated
This research is to evaluate the change of intermediate or nonculprit coronary lesion on lipid-lowering therapy via IVUSoptional and FFR
Detailed Description:
The patients who have intermediate CAD 30-80 diameter stenosis by visual estimation with FFR080 or nonculprit coronary artery disease with FFR08 after culprit coronary artery disease intervention will be enrolled FFR IVUSoptional and index of microcirculatory resistance IMR should be performed simultaneously Atorvastatin 20mg is a starting dose then up-titration will be done twice within each 46weeks until LDL target goal ① LDL70mgdl or ② statin naive 50 reduction from baseline LDL current statin user 30 reduction from baseline LDL First titration will be atorvastatin 40mg second will be atorvastatin 80mg If patients have any adverse effect on atorvastatin the dose of atorvastatin can be adjusted by investigators decision Official clinical follow-up except visit for statin dose titration will occur at 1 12 months after index procedure Follow-up coronary angiography FFRIMRand IVUSoptional will be performed 12 months after index procedure
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