Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
NCT ID: NCT07254572
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2025-07-10
2029-08-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DAPAGLIFLOZIN
Dapagliflozin + OMT \& Lifestyle Intervention
Optimal Medical Therapy (OMT) And Lifestyle Intervention
* cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines
* dietary counselling
* body weight management
* advice on optimizing physical activity levels
* advice on how to quit smoking if applicable
* psychological counselling
Dapagliflozin (Forxiga)
Dapagliflozin 10 mg daily
SEMAGLUTIDE
Semaglutide + OMT \& Lifestyle Intervention
Optimal Medical Therapy (OMT) And Lifestyle Intervention
* cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines
* dietary counselling
* body weight management
* advice on optimizing physical activity levels
* advice on how to quit smoking if applicable
* psychological counselling
Semaglutide 14 MG [Rybelsus]
Semaglutide 3 mg daily - up-titrated to 7 mg daily if well tolerated - up-titrated to 14 mg daily if well tolerated
METFORMIN
Metformin + OMT \& Lifestyle Intervention
Optimal Medical Therapy (OMT) And Lifestyle Intervention
* cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines
* dietary counselling
* body weight management
* advice on optimizing physical activity levels
* advice on how to quit smoking if applicable
* psychological counselling
Metformin
Metformin 500 mg daily (up-titrated to 1000 mg daily if indicated)
Interventions
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Optimal Medical Therapy (OMT) And Lifestyle Intervention
* cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines
* dietary counselling
* body weight management
* advice on optimizing physical activity levels
* advice on how to quit smoking if applicable
* psychological counselling
Semaglutide 14 MG [Rybelsus]
Semaglutide 3 mg daily - up-titrated to 7 mg daily if well tolerated - up-titrated to 14 mg daily if well tolerated
Dapagliflozin (Forxiga)
Dapagliflozin 10 mg daily
Metformin
Metformin 500 mg daily (up-titrated to 1000 mg daily if indicated)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Medical Research Agency, Poland
OTHER_GOV
National Institute of Cardiology, Warsaw, Poland
OTHER
Responsible Party
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Principal Investigators
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Jan Henzel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiology
Mariusz Kruk, MD, PhD
Role: STUDY_CHAIR
National Institute of Cardiology
Cezary Kępka, MD, PhD
Role: STUDY_CHAIR
National Institute of Cardiology
Locations
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National Institute of Cardiology, Department of Coronary Artery and Structural Heart Diseases
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Kinga Kotlińska
Role: primary
Agnieszka Nowicka
Role: backup
References
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https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-22/diabetes-total-risk-benefit-of-sglt2-inhibitors-and-glp1-agonists#.ZC8_KhOdj2E.link
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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CSDS.IV/VIII/2023
Identifier Type: -
Identifier Source: org_study_id