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

Sponsor
National Institute of Cardiology, Warsaw, Poland
Study ID
NCT07254572
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary Artery Disease
  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 14 MG [Rybelsus] — DRUG
    Semaglutide 3 mg daily - up-titrated to 7 mg daily if well tolerated - up-titrated to 14 mg daily if well tolerated
  • Dapagliflozin (Forxiga) — DRUG
    Dapagliflozin 10 mg daily
  • Metformin — DRUG
    Metformin 500 mg daily (up-titrated to 1000 mg daily if indicated)
  • Optimal Medical Therapy (OMT) And Lifestyle Intervention — BEHAVIORAL
    * 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

Study Details

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.

Key Dates

Start date
Jul 10, 2025
Status verified
Jul 2025
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DAPAGLIFLOZIN
    Dapagliflozin + OMT \& Lifestyle Intervention
  • Experimental: SEMAGLUTIDE
    Semaglutide + OMT \& Lifestyle Intervention
  • Active Comparator: METFORMIN
    Metformin + OMT \& Lifestyle Intervention

Primary Outcome Measure

Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS) [ Time Frame: 24 months ]

Central Contacts

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