Actively Recruiting
Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs 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
211 weeks
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
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
Official 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 18 to 80 years
- Diagnosed coronary artery disease confirmed by coronary CT scan showing at least 20% stenosis in arteries with reference diameter >2.5 mm or status after percutaneous coronary revascularization
- Coronary CT scan performed less than 3 months before inclusion and of good quality
- Pre-diabetic status defined by fasting blood glucose 100-125 mg%, 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 lifestyle management for at least 4 weeks
- Willing and able to give informed consent and comply with study requirements
You will not qualify if you...
- Severe valvular heart defect
- Clinical condition requiring surgical treatment of coronary artery disease
- Status after coronary artery bypass surgery
- Diagnosed diabetes or Hba1c 6.5% or higher at screening
- Other severe medical conditions requiring scheduled hospital treatment at study time
- Severe musculoskeletal conditions needing specific rehabilitation
- Diagnosed heart failure
- Presence of artificial heart valve, cardiac pacing system, or implantable device
- Severe arrhythmia or unexplained loss of consciousness
- Other contraindications to physical activity
- No consent to participate
- Use of glucose-lowering drugs other than metformin
- Use of weight-loss drugs
- History of bariatric surgery
- Diagnosed liver disease or ALT, AST above three times the upper limit of normal
- Uncompensated hyperthyroidism
- Pancreatic cancer
- Medullary thyroid cancer
- History of anaphylactic shock after iodine contrast
- Chronic kidney disease with eGFR less than 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 known contraindications to metformin, dapagliflozin, or semaglutide treatment
AI-Screening
AI-Powered Screening
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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
CONTACT
K
Kinga Kotlinska
CONTACT
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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