Sodium-glucose cotransporter-2 inhibitors to stABiLizE coronary atherosclerosis pro-gression after acute Myocardial Infarction in women and men with diabetes mellitus
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- The primary endpoint will be the change in total coronary percentage atheroma volume (PAV) on native (untreated) segments assessed by coronary CT angiography (CCTA) from baseline to 12 months follow-up. Change in PAV is defined as the difference between PAV at baseline and PAV at 12 months follow-up (PAV change = baseline PAV - 12 months PAV).
研究概览
简要总结
To evaluate the effect of SGLT2i on coronary atheroscle-rosis progression on native (untreated) coronary segments in diabetic patients after an AMI treated with successful PCI.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Established diagnosis of non-insulin-dependent diabetes mellitus
- •Hospital admission for AMI (with or without ST-segment elevation); AMI diagnosis should be confirmed with a troponin measurement according to the Fourth Universal Definition of Myocardial Infarction
- •Successful PCI
- •Complete revascularization obtained within the index hospitalization
- •Ability to provide informed consent
排除标准
- •Known intolerance/contraindications to SGLT2i therapy
- •Ongoing treatment with SGLT2i at the time of AMI
- •Contraindications to undergo CCTA
- •Insulin-dependent diabetes mellitus
- •Incomplete revascularization with indication to staged PCI on non-culprit lesions
- •Left ventricular ejection fraction <35% prior to discharge
- •Known allergy to aspirin or ticagrelor
- •Known pregnancy
- •Life expectancy <1 year for non-cardiac conditions
结局指标
主要结局
The primary endpoint will be the change in total coronary percentage atheroma volume (PAV) on native (untreated) segments assessed by coronary CT angiography (CCTA) from baseline to 12 months follow-up. Change in PAV is defined as the difference between PAV at baseline and PAV at 12 months follow-up (PAV change = baseline PAV - 12 months PAV).
The primary endpoint will be the change in total coronary percentage atheroma volume (PAV) on native (untreated) segments assessed by coronary CT angiography (CCTA) from baseline to 12 months follow-up. Change in PAV is defined as the difference between PAV at baseline and PAV at 12 months follow-up (PAV change = baseline PAV - 12 months PAV).
次要结局
- The secondary endpoints will include: inflammatory biomarkers, biochemical markers of glycaemic control, features of high-risk plaque composition evaluated at CCTA, degree of neointimal hyper-plasia on treated coronary segments at CCTA, adherence to therapy.
研究者
Prof. Giulio Stefanini
Scientific
Humanitas Mirasole S.p.A.