Comparing diabetes medicines to slow or reverse artery plaque in people with coronary artery disease and prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with coronary atherosclerosis confirmed by coronary CT and prediabetic blood glucose or HbA1c levels will be assigned to receive oral semaglutide (14 mg), dapagliflozin, or metformin alongside optimal medical therapy and lifestyle support. Participants will be followed for 24 months with coronary CT imaging to measure progression or regression of plaque and changes in plaque characteristics. The trial will also monitor standard cardiovascular risk factors and medication tolerability. Outcomes focus on change in coronary atherosclerosis burden and plaque composition compared between the treatment groups.

Why it matters

Who can join: the full rules

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

Where it's running

• National Institute of Cardiology, Department of Coronary Artery and Structural Heart Diseases
  Warsaw, Poland Recruiting

Study contacts

• Principal investigator: Jan Henzel, MD, PhD — National Institute of Cardiology
• Study coordinator: Jan Henzel, MD, PhD
• Email: jhenzel@ikard.pl
• Phone: +48 22 343 43 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.