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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)
EU CTIS ID: 2023-508525-27-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Severe valvular disease
- Severe diseases of the musculoskeletal system requiring specific rehabilitation recommendations
- Decompensated heart failure
- Lack of consent to participate in the study
- Severe arrhythmia/unexplained loss of consciousness
- Other contraindications to physical exercise
See the full eligibility criteria
- 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
- Severe valvular disease
- Severe diseases of the musculoskeletal system requiring specific rehabilitation recommendations
- Decompensated heart failure
- Lack of consent to participate in the study
- Severe arrhythmia/unexplained loss of consciousness
- Other contraindications to physical exercise
- Presence of an artificial valve, cardiac pacing system or other implantable device (e.g. cardioverter-defibrillator)
- Use of glucose-lowering medications other than metformin
- Use of weight loss medications
- Condition after bariatric surgery
- Diagnosed liver disease or ALT, AST greater than three times the upper limit of normal at the screening visit
- History of pancreatitis or active pancreatitis
- Decompensated hyperthyroidism
- History of anaphylactic shock after administration of iodine contrast
- Chronic kidney disease (GFR <60 ml/min/1.73 m2)
- Participation in another clinical trial
- Medullary thyroid cancer
- Pancreatic cancer
- Body mass index (BMI) >40 kg/m2
- A clinical condition requiring surgical treatment of coronary artery disease
- Pregnancy/lactation
- Other known contraindications to treatment with metformin, dapagliflozin or semaglutide
- Condition after coronary artery bypass surgery
- Diagnosed diabetes or Hba1c>6.5 mg% at the time of screening/randomization visit
- Other serious illnesses requiring planned hospital treatment during the examination
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.