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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05368545
Other study ID # AahusUH
Secondary ID 2019-001912-50
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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