Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05368545
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2022-05-06
Brief Title:
Influence of Lipid Lowering on Impaired Coronary Flow
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain
Status:
COMPLETED
Status Verified Date:
2022-11
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:
None
Brief Summary:
This study assess in patients with stable chest pain and coronary artery disease CAD determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow
Detailed Description:
Multicenter prospective study 105 patients with stable chest pain and moderate CAD statin naive and LDL cholesterol 2 mM and at least one translesional FFRct value 081 are randomized patients with significant CAD in the left main or other proximal segments are excluded from the study to either atorvastatin 40 mg daily or rosuvastatin 40 mg ezetimibe 10 mg daily treatment Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation HeartFlow are performed The primary endpoint is changes in FFRct values from 0 to 18 months Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001912-50 | EUDRACT_NUMBER | None | None |