A multiarm, randomized, open label Clinical study comparing AntiatheroSClerotic efficacy of selected Antidiabetic agents in patients with coronary artery disease and preDiabetES. A randomised clinical trial (CASCADES)
Key facts
- Where
- Warsaw, LengyelországSee the site
- Phase
- 4. fázis
Where in Lengyelország
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Trial code
- EU 2023-508525-27-00
- Record updated
- 2025. augusztus 27.
- Original description
To compare anti-atherosclerotic efficacy of treatment with oral GLP-1 agonist (semaglutide) vs SGLT-2 inhibitor (dapagliflozin), as compared to metformin, atop optimal dietand lifestyle modification-based therapy in patients with coronary artery disease (CAD) and prediabetes. The diagnosis of CAD will be defined as coronary atherosclerosis confirmed in contrast coronary computed tomography angiography (CCTA). The primary outcome is the effect of treatment to the coronary plaque progression/regression assessed in CCTA over the observation time of 24 months.Read full original descriptionShow less
To compare anti-atherosclerotic efficacy of treatment with oral GLP-1 agonist (semaglutide) vs SGLT-2 inhibitor (dapagliflozin), as compared to metformin, atop optimal dietand lifestyle modification-based therapy in patients with coronary artery disease (CAD) and prediabetes. The diagnosis of CAD will be defined as coronary atherosclerosis confirmed in contrast coronary computed tomography angiography (CCTA). The primary outcome is the effect of treatment to the coronary plaque progression/regression assessed in CCTA over the observation time of 24 months.
Inclusion: Age 18-80; Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of >2.5 mm detected in a coronary CT scan or after percutaneous coronary revascularization); Core CT scan performed <3 months after inclusion in the study, of at least good quality; Prediabetes defined as fasting blood glucose 100-125 mg% or Hba1c 5.70 6.49% (measurement documented during the screening/randomization visit or within 30 days before the screening/randomization visit) or a documented positive result of the oral stress test glucose (fasting blood glucose 100-125 mg% and 140-199 mg% 2 hours after an oral load of 75 g of glucose) performed within 30 days before the screening/randomization visit; Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management, for at least 4 weeks; Willingness and ability to provide informed consent for participation in the study; Capability and willingness, in the opinion of the investigator, to comply with all study requirements.
Exclusion: Use of weight loss medications; Other known contraindications to treatment with metformin, dapagliflozin or semaglutide; Severe valvular disease; Severe diseases of the musculoskeletal system requiring specific rehabilitation recommendations; Decompensated heart failure; Severe arrhythmia/unexplained loss of consciousness; Presence of an artificial valve, cardiac pacing system or other implantable device (e.g. cardioverter-defibrillator); Condition after bariatric surgery; History of pancreatitis or active pancreatitis; History of anaphylactic shock after administration of iodine contrast; Medullary thyroid cancer; Pancreatic cancer; A clinical condition requiring surgical treatment of coronary artery disease; Condition after coronary artery bypass surgery; Other serious illnesses requiring planned hospital treatment during the examination; Use of glucose-lowering medications other than metformin; Diagnosed liver disease or ALT, AST greater than three times the upper limit of normal at the screening visit; Chronic kidney disease (GFR <60 ml/min/1.73 m2); Diagnosed diabetes or Hba1c>6.5 mg% at the time of screening/randomization visit; Lack of consent to participate in the study; Other contraindications to physical exercise; Decompensated hyperthyroidism; Participation in another clinical trial; Body mass index (BMI) >40 kg/m2; Pregnancy/lactation.