NCT07254572RecruitingPhase 4
Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 10 Jul 2025
- Primary completion date
- 1 Aug 2029
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Diseases
- Coronary artery disease
- NCT number
- NCT07254572
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 300
- From 10 Jul 2025 to the primary completion date, 1 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Status after coronary artery bypass surgery
- Use of weight-loss drugs
- Other known contraindications to treatment with metformin, dapagliflozin or semaglutide
Other illness
- Clinical condition requiring surgical treatment of coronary artery disease
- Other severe medical conditions requiring scheduled hospital treatment at the time of the study
- Severe musculoskeletal conditions requiring specific rehabilitation recommendations
- Diagnosed heart failure
- Presence of an artificial valve, cardiac pacing system or other implantable device (such as a cardioverter defibrillator)
- Severe arrhythmia/unexplained loss of consciousness
- Condition after bariatric surgery
- Pancreatic cancer
- Medullary thyroid cancer
- History of anaphylactic shock after iodine contrast administration
- History of pancreatitis or active pancreatitis
Lab values
- Diagnosed diabetes or Hba1c\>=6.5% at screening/randomization appointment
- Use of glucose-lowering drugs other than metformin
- Diagnosed liver disease or ALT, AST above three times the upper limit of normal at screening appointment
- Chronic kidney disease (eGFR \<45 ml/min/1.73 m2)
Other
- Severe valvular defect
- Other contraindications to physical activity
- No consent to participate in the study
- Uncompensated hyperthyroidism
- Body mass index (BMI) \>40 kg/m2
- Pregnancy/lactation
- Participation in another clinical trial
Who the study is looking for
- Age 18 - 80
- Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of \>2.5 mm or status after percutaneous coronary revascularization procedure found on coronary CT scan)
- Coronary CT scan performed \<3 months after inclusion in the study, at least of good quality
- Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening/randomization appointment or within 30 days prior to the screening/randomization appointment) or documented, positive result of an oral glucose load test (fasting blood glucose 100-125 mg% and 140-199 mg% 2h after a 75 g oral glucose load) performed up to 30 days before the screening/randomization appointment
- Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks
- Willing and able to give informed consent to participate in the study
- Willing and able, according to the researcher, to comply with all the requirements of the study
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Cardiology, Department of Coronary Artery and Structural Heart Diseases Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.