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

NCT07254572 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Jan Henzel, MD, PhD · National Institute of Cardiology

  • Mariusz Kruk, MD, PhD · National Institute of Cardiology

  • Cezary Kępka, MD, PhD · National Institute of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2029-08-01
Completion
2029-08-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254572 on ClinicalTrials.gov