2023-505270-15-00招募中Phase III and phase IV (Integrated)
The effects of tirzepatIDE on coronAry pLaque lipid content and myocardial microvascular function in people with overweight or obesity and CORonary disease
试验速览
- 阶段
- Phase III and phase IV (Integrated)
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Lipid core burden index of the three major coronary vessels (LCBI(total)) measured by NIRS imaging.
研究概览
简要总结
To investigate the effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression, plaque burden, and microvascular function in overweight and obese individuals with stable coronary artery disease.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •BMI equal to or above 25 kg/m2
- •Age 18 years or older
- •Referred to coronary angiography (CAG) for evaluation of stable coronary disease
- •Coronary atheromatosis by angiography (obstructive or non-obstructive)
- •max lipid core burden index 4 mm (maxLCBI4mm) >200 by near-infrared spectroscopy (NIRS) in at least one major vessel not subjected to coronary intervention
排除标准
- •History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at screening
- •Estimated glomerular filtration rate (eGFR <30 ml/min/1.53 m2)
- •History of pancreatitis or plasma amylase >3 times upper normal limit
- •Pregnancy or planned pregnancy
- •Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal)
- •Heart transplant recipient
- •Patient is currently enrolled in another research study that may interfere with the conduct of this study.
- •Patient has any medical illness (e.g. cancer) that may cause non-compliance with the protocol or is associated with a life expectancy less than 1 year.
- •Inability to understand the requirements of the study and to provide informed consent
- •Medical illness requiring long-term treatment with systemic glucocorticoidsteroids
- •Patients who will not be available for study-required visits in the judgment of the Investigator
- •Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)
- •Coronary disease requiring coronary bypass surgery
- •Coronary disease requiring complex or high-risk PCI (e.g. chronic total occlusion of a major vessel or need for extensive rotablation).
- •Coronary anatomy or pathology precluding the safe performance of intravascular imaging in at least one major vessel not subjected to intervention
- •Left main stenosis (≥50% diameter or haemodynamically significant)
- •Chronic total occlusion of any major coronary vessel
- •Treatment with glucagon-like peptide 1 (GLP-1) agonists
- •History of coronary artery bypass surgery (CABG)
- •Planned cardiovascular intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of screening or at randomisation
- •History of heart failure New York Heart Association (NYHA) class III or IV
- •Left ventricular ejection fraction (LVEF) ≤35%
结局指标
主要结局
Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Lipid core burden index of the three major coronary vessels (LCBI(total)) measured by NIRS imaging.
Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Lipid core burden index of the three major coronary vessels (LCBI(total)) measured by NIRS imaging.
次要结局
- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Total coronary plaque burden measured by coronary intravascular ultrasound (IVUS) imaging assessed by percent atheroma volume (PAV)
- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Number of high-risk coronary lesions characterized by maximum lipid core burden index of a 4 mm examined vessel (maxLCBI(4mm)) ≥325 and plaque burden ≥70%
- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo microvascular function assessed by invasive coronary thermodilution technique (CFR)
研究者
Christine Rode
Scientific
Steno Diabetes Center Copenhagen
研究点 (2)
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