Influence of Lipid Lowering on Impaired Coronary Flow

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: High intensity lipid lowering


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual care lipid lowering<br>Usual care: atorvastatin 40 mg | Drug: High intensity lipid lowering<br>* Two different regimens of drugs with different effects on LDL lowering<br>* Other names: Usual care lipid lowering;|
| Experimental: Intensive lipid lowering<br>Intensive: rosuvastatin 40 mg + ezetimibe 10 mg | Drug: High intensity lipid lowering<br>* Two different regimens of drugs with different effects on LDL lowering<br>* Other names: Usual care lipid lowering;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FFRct values | CT derived FFR | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FFRct values | CT derived FFR | 9 months | 
| Changes in low density plaque volumes | CT determined plaque volumes | 0-9, and 0-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statin, fractional flow reserve, CT derived fractional flow reserve, coronary artery disease, ischemic heart disease, stable chest pain, blood cholesterol level