Influence of Lipid Lowering on Impaired Coronary Flow

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: High intensity lipid lowering

• Registration Number: NCT05368545
• Lead Sponsor: Aarhus University Hospital

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 \<0.81 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 Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Primary Completion: 2024-04-17
• Study Completion: 2024-04-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Age ≥35 y
• Symptoms suggestive of stable CAD
• No pre-CTA known CAD
• At least one lesion with FFRct <0.81
• Sinus rhythm
• LDL cholesterol >2.0 mM
• Statin use >2 months
• Life expentancy < 3 years
• Signed informed consent

Exclusion Criteria

• Known CAD
• Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
• Significant CAD in the left main or proximal coronary segments
• Referral to invasive catheterization
• Statin intolerance
• BMI >40
• Allergy to ionidated contrast
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care lipid lowering	High intensity lipid lowering	Usual care: atorvastatin 40 mg
Intensive lipid lowering	High intensity lipid lowering	Intensive: rosuvastatin 40 mg + ezetimibe 10 mg

Primary Outcome Measures

Name	Time	Method
Changes in FFRct values	18 months	CT derived FFR

Secondary Outcome Measures

Name	Time	Method
Changes in FFRct values	9 months	CT derived FFR
Changes in low density plaque volumes	0-9, and 0-18 months	CT determined plaque volumes

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denamrk, Denmark