Coronary Artery DiseaseNCT05368545
Influence of Lipid Lowering on Impaired Coronary Flow
A study testing High intensity lipid lowering in people with Coronary Artery Disease, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- High intensity lipid lowering
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2020to 17 Apr 2024
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥35 y
- Symptoms suggestive of stable CAD
- No pre-CTA known CAD
- At least one lesion with FFRct <0.81
- Sinus rhythm
- LDL cholesterol >2.0 mM
Show all 9Show fewer
- Statin use >2 months
- Life expentancy < 3 years
- Signed informed consent
Who cannot join
- Known CAD
- Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
- Significant CAD in the left main or proximal coronary segments
- Referral to invasive catheterization
- Statin intolerance
- BMI >40
- Allergy to ionidated contrast
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain
This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow
Read the detailed description
Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol >2 mM), and at least one translesional FFRct value <0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.
- Conditions
- Coronary Artery Disease
- Being tested
- High intensity lipid lowering
- Keywords
- fractional flow reserve, CT derived fractional flow reserve, coronary artery disease, ischemic heart disease, stable chest pain, statin, blood cholesterol level
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity lipid loweringDrug
Also called Usual care lipid lowering
Two different regimens of drugs with different effects on LDL lowering
| Study group | Role | What they receive |
|---|---|---|
| usual care lipid lowering | Active comparator | Usual care: atorvastatin 40 mg Receives: Drug: High intensity lipid lowering |
| Intensive lipid lowering | Experimental | Intensive: rosuvastatin 40 mg + ezetimibe 10 mg Receives: Drug: High intensity lipid lowering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FFRct values
CT derived FFR
Measured: 18 months
Secondary outcomes (2)
Changes in FFRct values
CT derived FFR
Measured: 9 months
Changes in low density plaque volumes
CT determined plaque volumes
Measured: 0-9, and 0-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 May 2020
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HeartFlow, Inc.
- Responsible party
- Principal investigator, Bjarne Linde Nørgaard, Aarhus University Hospital
- Investigators
- Bjarne Norgaard, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368545
- Sponsor's protocol ID
- AahusUH
- Other IDs
- 2019-001912-50, 2019
- Status last verified
- Apr 2025
- First submitted
- 6 May 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain
- ClinicalTrials.gov ID
- NCT05368545
- Acronym / sponsor ID
- AahusUH
- Conditions
- Coronary Artery Disease
- Keywords
- fractional flow reserve, CT derived fractional flow reserve, coronary artery disease, ischemic heart disease, stable chest pain, statin, blood cholesterol level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- HeartFlow, Inc.
- Study start
- 15 May 2020 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 10 May 2022 (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.
This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow
Detailed description
Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol >2 mM), and at least one translesional FFRct value <0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care lipid lowering | Active comparator | Drug: High intensity lipid loweringUsual care: atorvastatin 40 mg |
| Intensive lipid lowering | Experimental | Drug: High intensity lipid loweringIntensive: rosuvastatin 40 mg + ezetimibe 10 mg |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥35 y
- Symptoms suggestive of stable CAD
- No pre-CTA known CAD
- At least one lesion with FFRct <0.81
- Sinus rhythm
Key exclusion criteria (8 listed)
- Known CAD
- Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
- Significant CAD in the left main or proximal coronary segments
- Referral to invasive catheterization
- 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 |
|---|---|---|
| High intensity lipid loweringAlso: Usual care lipid loweringTwo different regimens of drugs with different effects on LDL lowering | Drug | Intensive lipid lowering, usual care lipid lowering |
Primary outcome
Changes in FFRct values
Time frame: 18 months
CT derived FFR
2 secondary outcomes
Changes in FFRct values
Time frame: 9 months
Changes in low density plaque volumes
Time frame: 0-9, and 0-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- 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 Norgaard, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity lipid lowering in people with Coronary Artery Disease, run by Aarhus University Hospital at 1 site 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 8 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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FFRct values (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.