Actively Recruiting
A Randomized, Open-label Clinical Trial Comparing Semaglutide, Dapagliflozin, and Metformin for Anti-atherosclerotic Effects in Patients With Coronary Artery Disease and Pre-diabetes
Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2025-11-28
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Cardiology, Warsaw, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of three different antidiabetic drugs—semaglutide, dapagliflozin, and metformin—on patients with pre-diabetes and coronary artery disease. The study aims to compare how these treatments influence the progression or regression of coronary atherosclerosis, changes in plaque characteristics, and control of cardiovascular risk factors over 24 months. Coronary artery disease diagnosis is confirmed by coronary CT scans showing atherosclerosis. Participants will be randomly assigned to receive either semaglutide (started at 3 mg daily and increased to 14 mg daily if tolerated), dapagliflozin (10 mg daily), or metformin (500 mg daily, up to 1000 mg if needed). All groups will also receive optimal medical therapy and lifestyle interventions including cardiological counseling, dietary advice, physical activity guidance, smoking cessation support if applicable, and psychological counseling. During the study, participants will undergo evaluations to assess coronary artery disease progression using coronary CT scans and monitor changes in cardiovascular risk factors and body measurements. Researchers will track compliance with physical activity and diet, inflammatory and lipid markers, blood sugar control, and major cardiovascular events over the 24-month period. Safety and treatment effects will be carefully monitored throughout the trial period.
CONDITIONS
Brief Title
Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed coronary artery disease confirmed by coronary CT scan showing ≥20% stenosis or status after percutaneous coronary revascularization
- Coronary CT scan performed within 3 months before study inclusion, of good quality
- Pre-diabetic status defined by fasting blood glucose 100-125 mg% or HbA1c 5.70-6.49%, or positive oral glucose load test within 30 days before screening
- Stable treatment and control of cardiovascular risk factors including diet and lifestyle for at least 4 weeks
- Willing and able to provide informed consent
- Able to comply with all study requirements as determined by the researcher
You will not qualify if you...
- Severe valvular heart defect
- Clinical condition requiring surgical treatment of coronary artery disease
- History of coronary artery bypass surgery
- Diagnosed diabetes or HbA1c ≥6.5% at screening
- Severe medical conditions requiring hospital treatment at study time
- Severe musculoskeletal conditions needing specific rehabilitation
- Diagnosed heart failure
- Presence of artificial heart valve, pacemaker, or implantable device
- Severe arrhythmia or unexplained loss of consciousness
- Contraindications to physical activity
- No consent to participate
- Use of glucose-lowering drugs other than metformin
- Use of weight-loss medications
- History of bariatric surgery
- Diagnosed liver disease or elevated liver enzymes above three times normal
- Uncompensated hyperthyroidism
- Pancreatic cancer
- Medullary thyroid cancer
- History of anaphylactic shock after iodine contrast
- Chronic kidney disease with eGFR <45 ml/min/1.73 m2
- History or active pancreatitis
- Body mass index over 40 kg/m2
- Pregnancy or breastfeeding
- Participation in another clinical trial
- Other contraindications to treatment with metformin, dapagliflozin, or semaglutide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive one of three antidiabetic drugs—Semaglutide, Dapagliflozin, or Metformin—along with optimal medical therapy and lifestyle intervention to manage coronary artery disease and pre-diabetes.
Regular visits for treatment monitoring and counseling (visit frequency determined by study protocol)
Trial Site Locations
Total: 1 location
1
National Institute of Cardiology, Department of Coronary Artery and Structural Heart Diseases
Warsaw, Poland
Actively Recruiting
Research Team
J
Jan Henzel, MD, PhD
K
Kinga Kotlinska
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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