RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,001
- 试验地点
- 8
- 主要终点
- Net Adverse Clinical Event
研究概览
简要总结
Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty
详细描述
Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study.
Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion.
In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography.
- •Patient has no contraindication to percutaneous arterial access by both and transfemoral route.
- •Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
- •Patient and the treating physician agree that the subject will comply with all follow-up evaluations.
排除标准
- •Subject's age is <18 years and he has no acute ST-elevation myocardial infarction (ST elevation of a least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads).
- •Subject has had a recent stroke or TIA (<4 weeks), irrespective of age.
- •Patient has an international normalized ratio (INR) > 2.0, or other severe bleeding diathesis
- •The patient is pregnant or breastfeeding.
- •Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated).
- •7.Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- •8.Prior participation in this study.
研究组 & 干预措施
Radial
group of patients undergoing primary angioplasty by transradial approach
干预措施: Radial approach (Procedure)
Femoral
group of patients undergoing primary angioplasty by transfemoral approach
干预措施: Femoral approach (Procedure)
结局指标
主要结局
Net Adverse Clinical Event
时间窗: 30-day
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
次要结局
- Net Adverse Clinical Event(1-year)
- Hospital stay(30-day)
- Individual components of NACE(1-year)
- Total procedural and fluoroscopy times for the index procedure(1 day)
研究者
Enrico Romagnoli
MD, PhD
Policlinico Casilino ASL RMB