NCT04737408

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3 coronary-artery-disease

Timeline
Completed

Started May 2020

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

January 28, 2021

Last Update Submit

February 3, 2021

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, fractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • 18-month change in coronary flow

    Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)

    18 months

Secondary Outcomes (4)

  • 18-month change high risk coronary plaque volumes

    18 months

  • 18-month change in high risk coronary plaque features

    18-months

  • 18-month change in coronary vessel volumes

    18-months

  • 18-month change in indices of coronary inflammation

    18-months

Other Outcomes (1)

  • Reproducibility assessment

    9-months

Study Arms (2)

"Usual care"

ACTIVE COMPARATOR

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

Drug: Rosuvastatin 40mg

"Intensive care"

EXPERIMENTAL

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

Drug: Rosuvastatin 40mg

Interventions

Rosuvastatin 40mgDRUG

Rosuvastatin 40 mg

Also known as: Ezetimib 10mg
"Intensive care""Usual care"

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Fertile women must use safe contraception throughout the study period
  • Signed informed consent
  • \. 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)

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus, 8200 N, Denmark

RECRUITING

Southwestern Hospital Esbjerg

Esbjerg, 6700, Denmark

RECRUITING

Lillebaelt Hospital

Vejle, 7100, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rosuvastatin CalciumEzetimibe

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAzetidinesAzetines

Study Officials

  • Bjarne L Noergaard, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjarne L Noergaard, MD, PhD

CONTACT

+4540136570bnorgaard@dadlnet.dk

Martin B Mortensen, MD, PhD

CONTACT

+4523882155martin.bodtker.mortensen@clin.au.dk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label design
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, MD, PhD, FESC

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 3, 2021

Study Start

May 13, 2020

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)