Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)

Study Overview
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Brief Summary
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The FLOW-PROMOTE Study is an investigator-initiated, Danish multicenter study of patients with stable chest pain investigating whether lipid lowering is associated with recovery of impaired coronary flow as assessed by CT derived fractional flow reserve (FFRCT).

Detailed Description
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Multicenter study (4 centers in Denmark), including 120 patients with stable chest pain and hemodynamically significant coronary artery disease as assessed by FFRCT. By using two lipid lowering treatment strategies (usual vs intensive care) over 18 months, the effect on coronary plaque regression and flow recovery are assessed from repeated CT angiograms with plaque and FFRCT analyses at 9 and 18 months.

Official Title
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Influence of Intensive Lipid-lowering With Statin and Ezetimib Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain (The FLOW-PROMOTE Study)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Rosuvastatin 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms suggestive of stable coronary artery disease (CAD) No known CAD At least one coronary stenosis with >49% lumen reduction determined by CT angiography Sinus rhythm At least one lesion with FFRCT <0.81 (see below) Life expectancy >3 years Fertile women must use safe contraception throughout the study period Signed informed consent 5. LDL cholesterol >2.0 mM (patients already on lipid lowering medical therapy < 3 months can be included if meeting all of the above mentioned criteria) Exclusion Criteria: Unstable angina Known CAD Body mass index >40 Allergy to iodinated contrast media Known statin intolerance Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory) Significant left main coronary artery (stenosis >49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA FFRCT <0.81 over the left main coronary artery or the proximal left anterior descendens artery (LAD) segment, or <0.76 over the mid-LAD, proximal circumflex, right coronary artery or intermediate coronary segments Pregnancy (women with age >45 will be screened for pregnancy) Moderate to severe liver failure Estimated glomerular filtration rate (eGFR) < 60 ml/min Participation in another trial Does noes not wish to participate

Ages Eligible for Study
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Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care prevention: atorvastatin 40 mg per day for 18 months | Drug: Rosuvastatin 40mg<br>* Rosuvastatin 40 mg<br>* Other names: Ezetimib 10mg;|
| Experimental: Intensive care<br>Intensive care prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months | Drug: Rosuvastatin 40mg<br>* Rosuvastatin 40 mg<br>* Other names: Ezetimib 10mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18-month change in coronary flow | Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18-month change high risk coronary plaque volumes | Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months) | 18 months | 
| 18-month change in high risk coronary plaque features | Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months). | 18-months | 
| 18-month change in coronary vessel volumes | Will be assessed by calculating the vessel volume relative to myocardial mass (V/M) ratio determined from repetitive CT angiograms (0,9, and 18 months). | 18-months | 
| 18-month change in indices of coronary inflammation | Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months). | 18-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, fractional flow reserve