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

Bjarne Linde Noergaard

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Rosuvastatin 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04737408

Aarhus University Hospital

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

"Usual care"

Active Comparator group

Description:

"Usual care" prevention: atorvastatin 40 mg per day for 18 months

Treatment:

Drug: Rosuvastatin 40mg

"Intensive care"

Experimental group

Description:

"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months

Treatment:

Drug: Rosuvastatin 40mg