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Completed

NCT Number: NCT05368545

Influence of Lipid Lowering on Impaired Coronary Flow

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Denamrk, 8300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

High intensity lipid lowering

Drug

Two different regimens of drugs with different effects on LDL lowering

Other names: Usual care lipid lowering

Primary outcomes

  1. Changes in FFRct values

    Time frame: 18 months

    CT derived FFR

Secondary outcomes

  1. Changes in FFRct values

    Time frame: 9 months

    CT derived FFR

  2. Changes in low density plaque volumes

    Time frame: 0-9, and 0-18 months

    CT determined plaque volumes

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • HeartFlow, Inc.

Registry information

Official study title

Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 10, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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