Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)
NCT ID: NCT04737408
Last Updated: 2021-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2020-05-13
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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"Usual care"
"Usual care" prevention: atorvastatin 40 mg per day for 18 months
Rosuvastatin 40mg
Rosuvastatin 40 mg
"Intensive care"
"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months
Rosuvastatin 40mg
Rosuvastatin 40 mg
Interventions
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Rosuvastatin 40mg
Rosuvastatin 40 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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
40 Years
ALL
No
Sponsors
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Bjarne Linde Noergaard
OTHER
Responsible Party
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Bjarne Linde Noergaard
Associate Professor, MD, PhD, FESC
Principal Investigators
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Bjarne L Noergaard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Southwestern Hospital Esbjerg
Esbjerg, , Denmark
Lillebaelt Hospital
Vejle, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Aarhus University Hospital
Identifier Type: -
Identifier Source: org_study_id
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