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

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ClinicalTrials.gov Identifier: NCT04737408
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Bjarne Linde Noergaard, Aarhus University Hospital Skejby

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Rosuvastatin 40mg Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
Masking: None (Open Label)
Masking Description: Open label design
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: "Usual care"
"Usual care" prevention: atorvastatin 40 mg per day for 18 months
 Drug: Rosuvastatin 40mg
Rosuvastatin 40 mg
Other Name: Ezetimib 10mg
Experimental: "Intensive care"
"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months
 Drug: Rosuvastatin 40mg
Rosuvastatin 40 mg
Other Name: Ezetimib 10mg


Outcome Measures
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Primary Outcome Measures :
  1. 18-month change in coronary flow [ Time Frame: 18 months ]
    Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)


Secondary Outcome Measures :
  1. 18-month change high risk coronary plaque volumes [ Time Frame: 18 months ]
    Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months)

  2. 18-month change in high risk coronary plaque features [ Time Frame: 18-months ]
    Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months).

  3. 18-month change in coronary vessel volumes [ Time Frame: 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).

  4. 18-month change in indices of coronary inflammation [ Time Frame: 18-months ]
    Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months).


Other Outcome Measures:
  1. Reproducibility assessment [ Time Frame: 9-months ]
    There will be performed 2 CTA investigations at the 9 month follow-up. Reproducibility assessment of CT derived FFR, plaque markers, FAI and V/M ratio will be performed by calculation of standard error of measurement and within-subject coefficient of variation.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737408


Contacts
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Contact: Bjarne L Noergaard, MD, PhD +4540136570 bnorgaard@dadlnet.dk
Contact: Martin B Mortensen, MD, PhD +4523882155 martin.bodtker.mortensen@clin.au.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200 N
Contact: Bjarne L Noergaard, MD, PhD    +4540136570    bnorgaard@dadlnet.dk   
Contact: Martin B Mortensen, MD, PhD    +4523882155    martin.bodtker.mortensen@clin.au.dk   
Sub-Investigator: Jesper M Jensen, MD, PhD         
Southwestern Hospital Esbjerg Recruiting
Esbjerg, Denmark, 6700
Contact: Niels-Peter R Sand, MD, PhD    +4528409148    npsand@webspeed.dk   
Contact: Lone D Kristensen, MD    +4521422813    lone.dejbjerg@dadlnet.dk   
Lillebaelt Hospital Not yet recruiting
Vejle, Denmark, 7100
Contact: Martin Busk, MD, PhD    +4522473224    martin.busk@rsyd.dk   
Contact: Flemming H Steffensen, MD, PhD    +4551503862    flemming.hald@rsyd.dk   
Sponsors and Collaborators
Bjarne Linde Noergaard
Investigators
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Principal Investigator: Bjarne L Noergaard, MD, PhD Aarhus University Hospital
More Information
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Responsible Party: Bjarne Linde Noergaard, Associate Professor, MD, PhD, FESC, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT04737408    
Other Study ID Numbers: Aarhus University Hospital
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bjarne Linde Noergaard, Aarhus University Hospital Skejby:
coronary artery disease, fractional flow reserve
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors