NCT07254572招募中4 期
A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
National Institute of Cardiology, Warsaw, Poland1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年7月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS)
研究概览
简要总结
The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called "flozin") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80
- •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
排除标准
- •Severe valvular defect
- •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
研究组 & 干预措施
DAPAGLIFLOZIN
Experimental
Dapagliflozin + OMT & Lifestyle Intervention
干预措施: Dapagliflozin (Forxiga) (Drug)
DAPAGLIFLOZIN
Experimental
Dapagliflozin + OMT & Lifestyle Intervention
干预措施: Optimal Medical Therapy (OMT) And Lifestyle Intervention (Behavioral)
SEMAGLUTIDE
Experimental
Semaglutide + OMT & Lifestyle Intervention
干预措施: Semaglutide 14 MG [Rybelsus] (Drug)
SEMAGLUTIDE
Experimental
Semaglutide + OMT & Lifestyle Intervention
干预措施: Optimal Medical Therapy (OMT) And Lifestyle Intervention (Behavioral)
METFORMIN
Active Comparator
Metformin + OMT & Lifestyle Intervention
干预措施: Metformin (Drug)
METFORMIN
Active Comparator
Metformin + OMT & Lifestyle Intervention
干预措施: Optimal Medical Therapy (OMT) And Lifestyle Intervention (Behavioral)
结局指标
主要结局
Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS)
时间窗: 24 months
Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat) AND Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat)
次要结局
- Evaluation of change in lipid levels in patients treated with semaglutide vs. patients treated with flozin(24 months)
- Evaluation of change in the percentage of glycated hemoglobin (HbA1c) in patients treated with semaglutide vs. patients treated with flozin(24 months)
- Evaluation of change in the percentage of patients with normal blood pressure in patients treated with semaglutide vs. patients treated with flozin(24 months)
- Evaluation of the effect of each of the tested drugs vs. control group on progression of coronary artery disease(24 months)
- Comparison of the effect of semaglutide vs. flozin on coronary artery disease progression(24 months)
- Evaluation of the effect of each study drug vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease(24 months)
- Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease(24 months)
- Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease (plaque conversion)(24 months)
- Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk expressed as the dynamics of high-risk features(24 months)
- Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk on pericoronary fat attenuation index(24 months)
- Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body weight(24 months)
- Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body mass index(24 months)
- Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - total body fat(24 months)
- Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body cell mass(24 months)
- Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - fat to mass ratio(24 months)
- Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - visceral fat area(24 months)
- Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - waist-to-hip index(24 months)
- Evaluation of change in inflammatory parameters in patients treated with semaglutide vs. patients treated with flozin(24 months)
- Evaluation of change in the percentage of patients smoking tobacco or electronic cigarettes in patients treated with semaglutide vs. patients treated with flozin(24 months)
- Evaluation of compliance with physical activity recommendations in patients treated with semaglutide vs. patients treated with flozin(24 months)
- Evaluation of dietary compliance in patients treated with semaglutide vs. patients treated with flozin(24 months)
- Type 2 diabetes diagnosis(24 months)
- Evaluation of the onset of heart failure requiring hospitalization(24 months)
- Number of unscheduled hospitalizations(24 months)
- Number of major cardiovascular events and strokes (MACCE: death/myocardial infarction/revascularization/stroke) separately and combined(24 months)
- Homeostatic Model Change Assessment - Insulin Resistance (HOMA-IR)(12 and 24 months)
- Evaluation of change in the concentration of selected oxidative stress markers - catalase(12 months and 24 months)
- Evaluation of change in the concentration of selected oxidative stress markers - superoxide dismutase (SOD)(12 months and 24 months)
- Evaluation of change in the concentration of selected oxidative stress markers - Oxygen Radical Absorbance Capacity (ORAC)(12 months and 24 months)
- Evaluation of change in the concentration of selected oxidative stress markers - total antioxidant capacity (TAC)(12 months and 24 months)
研究者
研究点 (1)
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