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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

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT05368545
Study type Interventional
Source Aarhus University Hospital
Contact Bjarne Norgaard, MD, PhD
Phone +4540136570
Email [email protected]
Status Recruiting
Phase N/A
Start date May 15, 2020
Completion date September 30, 2025

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