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RECRUITING
NCT07254572
PHASE4

Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

Sponsor: National Institute of Cardiology, Warsaw, Poland

View on ClinicalTrials.gov

Summary

The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called "flozin") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months. The diagnosis of coronary artery disease will be defined as the presence of coronary atherosclerosis confirmed by coronary artery computed tomography (coronary CT). The study will evaluate the effect of treatment with flozin vs. semaglutide compared to treatment with metformin on the progression/regression of coronary atherosclerosis, change in plaque character, and control of cardiovascular risk factors.

Official title: A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-07-10

Completion Date

2029-08-01

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

DRUG

Semaglutide 14 MG [Rybelsus]

Semaglutide 3 mg daily - up-titrated to 7 mg daily if well tolerated - up-titrated to 14 mg daily if well tolerated

DRUG

Dapagliflozin (Forxiga)

Dapagliflozin 10 mg daily

DRUG

Metformin

Metformin 500 mg daily (up-titrated to 1000 mg daily if indicated)

BEHAVIORAL

Optimal Medical Therapy (OMT) And Lifestyle Intervention

* cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines * dietary counselling * body weight management * advice on optimizing physical activity levels * advice on how to quit smoking if applicable * psychological counselling

Locations (1)

National Institute of Cardiology, Department of Coronary Artery and Structural Heart Diseases

Warsaw, Poland