Coronary Artery DiseasePhase 3FlowPromoteNCT04737408
Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)
A Phase 3 study testing Rosuvastatin 40mg in people with Coronary Artery Disease, run by Bjarne Linde Noergaard at 3 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rosuvastatin 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesDenmark
- Study dates
- 13 May 2020to Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200 N
Bjarne L Noergaard, MD, PhD, +4540136570, bnorgaard@dadlnet.dk
Martin B Mortensen, MD, PhD, +4523882155, martin.bodtker.mortensen@clin.au.dk
- Recruiting
Southwestern Hospital Esbjerg
Esbjerg, 6700
Niels-Peter R Sand, MD, PhD, +4528409148, npsand@webspeed.dk
Lone D Kristensen, MD, +4521422813, lone.dejbjerg@dadlnet.dk
- Not yet recruiting
Lillebaelt Hospital
Vejle, 7100
Martin Busk, MD, PhD, +4522473224, martin.busk@rsyd.dk
Flemming H Steffensen, MD, PhD, +4551503862, flemming.hald@rsyd.dk
About this study
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)
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).
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Rosuvastatin 40mg
- Keywords
- coronary artery disease, fractional flow reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 40mgDrug
Also called Ezetimib 10mg
Rosuvastatin 40 mg
| Study group | Role | What they receive |
|---|---|---|
| "Usual care" | Active comparator | "Usual care" prevention: atorvastatin 40 mg per day for 18 months Receives: Drug: Rosuvastatin 40mg |
| "Intensive care" | Experimental | "Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months Receives: Drug: Rosuvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
18-month change in coronary flow
Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)
Measured: 18 months
Secondary outcomes (4)
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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start13 May 2020
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bjarne Linde Noergaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bjarne Linde Noergaard, Aarhus University Hospital Skejby
- Investigators
- Bjarne L Noergaard, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737408
- Sponsor's protocol ID
- Aarhus University Hospital
- Acronym
- FlowPromote
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mortensen MB, Iraqi N, Sand NPR, Busk M, Jensen JM, Madsen KT, Grove EL, Dey D, Kanstrup H, Pedersen K, Mathiassen ON, Hosbond S, Botker HE, Narula J, Norgaard BL. Intensive vs More Intensive Lipid-Lowering Therapy and Plaque Regression in Statin-Naive Patients: Prespecified Analyses From the FLOWPROMOTE Randomized Clinical Trial. JAMA Cardiol. 2026 Oct 30:e264788. doi: 10.1001/jamacardio.2026.4788. Online ahead of print.
PubMed 42961412
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04737408
- Acronym / sponsor ID
- FlowPromote / Aarhus University Hospital
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, fractional flow reserve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bjarne Linde NoergaardUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
| Arm | Type | Receives |
|---|---|---|
| "Usual care" | Active comparator | Drug: Rosuvastatin 40mg"Usual care" prevention: atorvastatin 40 mg per day for 18 months |
| "Intensive care" | Experimental | Drug: Rosuvastatin 40mg"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- Unstable angina
- Known CAD
- Body mass index >40
- Allergy to iodinated contrast media
- Known statin intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 40mgAlso: Ezetimib 10mgRosuvastatin 40 mg | Drug | "Intensive care", "Usual care" |
Primary outcome
18-month change in coronary flow
Time frame: 18 months
Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)
4 secondary outcomes
18-month change high risk coronary plaque volumes
Time frame: 18 months
18-month change in high risk coronary plaque features
Time frame: 18-months
18-month change in coronary vessel volumes
Time frame: 18-months
18-month change in indices of coronary inflammation
Time frame: 18-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 42961412Mortensen MB, Iraqi N, Sand NPR, Busk M, Jensen JM, Madsen KT, Grove EL, Dey D, Kanstrup H, Pedersen K, Mathiassen ON, Hosbond S, Botker HE, Narula J, Norgaard BL. Intensive vs More Intensive Lipid-Lowering Therapy and Plaque Regression in Statin-Naive Patients: Prespecified Analyses From the FLOWPROMOTE Randomized Clinical Trial. JAMA Cardiol. 2026 Oct 30:e264788. doi: 10.1001/jamacardio.2026.4788. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjarne L Noergaard, MD, PhD principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin 40mg in people with Coronary Artery Disease, run by Bjarne Linde Noergaard at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bjarne L Noergaard, MD, PhD (+4540136570, bnorgaard@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18-month change in coronary flow (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.