Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to 80 Years; no BMI minimum stated; conditions: Coronary Artery Disease; PreDiabetes
- Interventions
- Semaglutide 14 MG [Rybelsus]; Dapagliflozin (Forxiga); Metformin; Optimal Medical Therapy (OMT) And Lifestyle Intervention
- Conditions
- Coronary Artery Disease; PreDiabetes
- Phase and size
- Phase 4 · 300 participants
- Dates
- Start 2025-07-10
Primary completion 2029-08-01 - Sponsor
- National Institute of Cardiology, Warsaw, Poland (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will 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)24 months
02Eligibility
Who can take part
Inclusion Criteria: * 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 Exclusion Criteria: * Severe valvular defect * Clinical condition requiring surgical treatment of coronary artery disease * Status after coronary artery bypass surgery * Diagnosed diabetes or Hba1c\>=6.5% at screening/randomization appointment * 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 * Other contraindications to physical activity * No consent to participate in the study * Use of glucose-lowering drugs other than metformin * Use of weight-loss drugs * Condition after bariatric surgery * Diagnosed liver disease or ALT, AST above three times the upper limit of normal at screening appointment * Uncompensated hyperthyroidism * Pancreatic cancer * Medullary thyroid cancer * History of anaphylactic shock after iodine contrast administration * Chronic kidney disease (eGFR \<45 ml/min/1.73 m2) * History of pancreatitis or active pancreatitis * Body mass index (BMI) \>40 kg/m2 * Pregnancy/lactation * Participation in another clinical trial * Other known contraindications to treatment with metformin, dapagliflozin or semaglutide
03Change log
Registry changes
No changes recorded since the trial was added.