Influence of Lipid Lowering on Impaired Coronary Flow

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368545
• Other study ID #: AahusUH
• Secondary ID: 2019-001912-50
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: October 14, 2022

Study information

• Verified date: November 2022
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• High intensity lipid lowering
Two different regimens of drugs with different effects on LDL lowering

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Denamrk

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	HeartFlow, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in FFRct values	CT derived FFR	18 months
Secondary	Changes in FFRct values	CT derived FFR	9 months
Secondary	Changes in low density plaque volumes	CT determined plaque volumes	0-9, and 0-18 months