Status:
COMPLETED
Influence of Lipid Lowering on Impaired Coronary Flow
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
HeartFlow, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
35+ years
Phase:
NA
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 characteristic...
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 (pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT05368545
Start Date
May 15 2020
End Date
April 17 2024
Last Update
April 3 2025
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denamrk, Denmark, 8300