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NOT YET RECRUITING
NCT07474649
PHASE3

A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Official title: Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2026-08-15

Completion Date

2028-10-02

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

DRUG

Bempedoic acid

FDC: 180 mg

DRUG

Ezetimibe

FDC: 10 mg

DRUG

Rosuvastatin

20 mg dose

DRUG

Atorvastatin

40 mg dose

Locations (12)

Charité - Universitätsmedizin Berlin

Berlin, Germany

UKE Hamburg

Hamburg, Germany

Universität Mainz

Mainz, Germany

Heidelberg University

Mannheim, Germany

IRCCS Policlinico San Donato

Milan, Italy

Cardiology, IRCCS San Raffaele Scientific Institute

Milan, Italy

AOU Federico II di Napoli

Naples, Italy

IRCCS Ospedale Sacro Cuore - Don Calabria

Negrar, Italy

Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital San Rafael

Madrid, Spain

CUN (Clínica Universitaria de Navarra)

Madrid, Spain

Hospital Universitario Quironsalud Madrid

Madrid, Spain