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

Phase 3

• Conditions: Coronary Artery Disease
• Interventions: Drug: Rosuvastatin 40mg

• Registration Number: NCT04737408
• Lead Sponsor: Bjarne Linde Noergaard

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-05-13
• Study First Submitted: 2021-01-28
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-05
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Symptoms suggestive of stable coronary artery disease (CAD)

2. No known CAD

3. At least one coronary stenosis with >49% lumen reduction determined by CT angiography

4. Sinus rhythm

5. At least one lesion with FFRCT <0.81 (see below)

6. Life expectancy >3 years

7. Fertile women must use safe contraception throughout the study period

8. Signed informed consent

9. 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

1. Unstable angina
2. Known CAD
3. Body mass index >40
4. Allergy to iodinated contrast media
5. Known statin intolerance
6. Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory)
7. Significant left main coronary artery (stenosis >49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA
8. 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
9. Pregnancy (women with age >45 will be screened for pregnancy)
10. Moderate to severe liver failure
11. Estimated glomerular filtration rate (eGFR) < 60 ml/min
12. Participation in another trial
13. Does noes not wish to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Usual care"	Rosuvastatin 40mg	"Usual care" prevention: atorvastatin 40 mg per day for 18 months
"Intensive care"	Rosuvastatin 40mg	"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months

Primary Outcome Measures

Name	Time	Method
18-month change in coronary flow	18 months	Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)

Secondary Outcome Measures

Name	Time	Method
18-month change high risk coronary plaque volumes	18 months	Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months)
18-month change in high risk coronary plaque features	18-months	Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months).
18-month change in coronary vessel volumes	18-months	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-month change in indices of coronary inflammation	18-months	Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months).

Trial Locations

Locations (3)

Lillebaelt Hospital; 🇩🇰 Vejle, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Southwestern Hospital Esbjerg; 🇩🇰 Esbjerg, Denmark