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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: High intensity lipid lowering

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Denamrk
    • Aarhus, Denamrk, Denmark, 8300
      • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual care lipid lowering; Usual care: atorvastatin 40 mg	Drug: High intensity lipid lowering; Two different regimens of drugs with different effects on LDL lowering; Other Names: Usual care lipid lowering
Experimental: Intensive lipid lowering; Intensive: rosuvastatin 40 mg + ezetimibe 10 mg	Drug: High intensity lipid lowering; Two different regimens of drugs with different effects on LDL lowering; Other Names: Usual care lipid lowering

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in FFRct values	CT derived FFR	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in FFRct values	CT derived FFR	9 months
Changes in low density plaque volumes	CT determined plaque volumes	0-9, and 0-18 months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: HeartFlow, Inc.
• Investigators: Principal Investigator: Bjarne Norgaard, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): October 14, 2022
• Study Completion (Actual): October 14, 2022

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ischemic heart disease; coronary artery disease; CT derived fractional flow reserve; statin; fractional flow reserve; stable chest pain; blood cholesterol level
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AahusUH; 2019-001912-50 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No