NCT07254572 Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
| NCT ID | NCT07254572 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Institute of Cardiology, Warsaw, Poland |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2029-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-07-10 with a primary completion date of 2029-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Jan Henzel, MD, PhD
PRINCIPAL INVESTIGATOR
National Institute of Cardiology
Frequently Asked Questions
Who can join the NCT07254572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07254572 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07254572 currently recruiting?
Yes, NCT07254572 is actively recruiting participants. Contact the research team at jhenzel@ikard.pl for enrollment information.
Where is the NCT07254572 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07254572 clinical trial?
NCT07254572 is sponsored by National Institute of Cardiology, Warsaw, Poland. The principal investigator is Jan Henzel, MD, PhD at National Institute of Cardiology. The trial plans to enroll 300 participants.