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)

Phase 1

• Conditions: Coronary Artery Disease, Prediabetes, Coronary Atherosclerosis, Coronary Heart Disease; MedDRA version: 20.0Level: LLTClassification code: 10065542Term: Prediabetes Class: 10027433; MedDRA version: 20.0Level: LLTClassification code: 10068617Term: Coronary heart disease Class: 10007541; MedDRA version: 20.0Level: LLTClassification code: 10011093Term: Coronary atherosclerosis Class: 10007541; MedDRA version: 20.0Level: PTClassification code: 10011078Term: Coronary artery disease Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508525-27-00
• Lead Sponsor: arodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion 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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified