Influence of Lipid Lowering on Impaired Coronary Flow

Aarhus University Hospital

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Drug: High intensity lipid lowering

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05368545

2019-001912-50 (EudraCT Number)

AahusUH

Details and patient eligibility

About

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

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

usual care lipid lowering

Active Comparator group

Description:

Usual care: atorvastatin 40 mg

Treatment:

Drug: High intensity lipid lowering

Intensive lipid lowering

Experimental group

Description:

Intensive: rosuvastatin 40 mg + ezetimibe 10 mg

Treatment:

Drug: High intensity lipid lowering