Influence of Lipid Lowering on Impaired Coronary Flow
Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain
2 other identifiers
interventional
109
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started May 2020
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2024
CompletedApril 3, 2025
April 1, 2025
3.9 years
May 6, 2022
April 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in FFRct values
CT derived FFR
18 months
Secondary Outcomes (2)
Changes in FFRct values
9 months
Changes in low density plaque volumes
0-9, and 0-18 months
Study Arms (2)
usual care lipid lowering
ACTIVE COMPARATORUsual care: atorvastatin 40 mg
Intensive lipid lowering
EXPERIMENTALIntensive: rosuvastatin 40 mg + ezetimibe 10 mg
Interventions
Two different regimens of drugs with different effects on LDL lowering
Eligibility Criteria
You may qualify if:
- 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
- Statin use \>2 months
- Life expentancy \< 3 years
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- HeartFlow, Inc.collaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, Denamrk, 8300, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bjarne Norgaard, MD, PhD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, DMSc, PhD
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 10, 2022
Study Start
May 15, 2020
Primary Completion
April 17, 2024
Study Completion
April 17, 2024
Last Updated
April 3, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share