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Taking people in PolandPhase 4

Semaglutide, dapagliflozin or metformin for coronary artery plaque with prediabetes

Compares semaglutide, dapagliflozin and metformin in coronary artery disease with prediabetes.

Key facts

Who runs it
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Where
Warsaw, PolandSee the site
Registry title
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)
Status
Recruiting
Phase
Phase 4
People taking part
300 people, planned
Started
10 Jul 2025
Expected to end
1 Aug 2029
Type of study
Interventional
Record updated
27 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with coronary artery disease and prediabetes. It compares semaglutide, dapagliflozin and metformin on plaque in the heart arteries over 24 months.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Coronary artery disease shown on a coronary CT scan (stenosis of at least 20%, or after a stent or similar procedure), together with prediabetes. Diabetes is not allowed.
Earlier treatment
Stable treatment of heart risk factors, including diet and lifestyle, for at least 4 weeks. No diabetes drugs other than metformin, and no weight loss drugs.
Biomarker or test result
Prediabetes: fasting blood glucose 100-125 mg% or Hba1c 5.70 6.49%, or a positive oral glucose test. A core CT scan of good quality made less than 3 months before joining.

Main reasons for not taking part

  • Diagnosed diabetes or Hba1c above 6.5 mg%
  • Chronic kidney disease (GFR below 60 ml/min/1.73 m2)
  • Decompensated heart failure or severe valve disease
  • Condition after bypass surgery or bariatric surgery
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 32 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Poland

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, PolandTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Semaglutide, dapagliflozin or metformin for coronary artery plaque with prediabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
27 August 2025