Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,164
- 试验地点
- 25
- 主要终点
- Target lesion failure at 1-year follow-up
研究概览
简要总结
This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology.
It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design.
The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(must meet all):
- •Patients ≥18 years who understands the nature of the study and provides written informed consent.
- •Diagnosis of diabetes according to the American Diabetes Association diagnostic criteria (*)
- •Documented silent ischemia, stable angina, unstable angina, or myocardial infarction (with or without ST elevation).
- •At least one de novo coronary lesion with stenosis of more than 50% in a vessel with a reference vessel diameter of 2.25 to 4.5 mm by visual estimation. Coronary anatomy is suitable for PCI (patients with potential CABG indication should be eligible for PCI after a multidisciplinary evaluation in a Heart Team).
排除标准
- •Cardiogenic shock or resuscitation
- •Comorbidity with anticipated life expectancy to 24 months
- •Inability to consent due to mechanical ventilation
- •Pregnant female patient
- •Conditions that could preclude a minimal of 1 month of DAPT (such as, but not limited to: severe liver failure, platelet count <100,000 cells/mm3, recent gastrointestinal bleeding or history of bleeding diathesis or coagulopathy)
- •Contraindication or known allergy to aspirin, heparin, P2Y12 inhibitors, cobalt and/or chromium metal alloys, sirolimus or derivates, polyurethane, or contrast media (for contrast-media allergy, patients that might be safely and adequately pre-medicated should be allowed to enter the study).
- •Currently enrolled in another clinical trial.
结局指标
主要结局
Target lesion failure at 1-year follow-up
时间窗: 12 months
A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 12-months follow-up.
Target lesion failure at 2-years follow-up
时间窗: 24 months
A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 24-months follow-up.
次要结局
- Target vessel myocardial infarction(12 and 24 months)
- Stent thrombosis(12 and 24 months)
- Cardiac death(12 and 24 months)
- Non-target lesion revascularization(12 and 24 months)
- Target vessel revascularization(12 and 24 months)
- Target lesion revascularization(12 and 24 months)
研究者
Dr Rafael Romaguera
Principal Investigator
Spanish Society of Cardiology