A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AGE>80 Non-STEMI - characteristic chest pain accompanied by
- •Typical ischaemic ECG changes
- •A troponin rise
- •Suitable for conservative or invasive strategy
排除标准
- •Lack of suitability for whatever clinical reason to be randomised eg dementia, co-morbidity
- •Acute STEMI
- •Cardiogenic shock
- •Platelet count =50 x 109/mm3
- •Patient life expectancy < 1 year
- •Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
- •Recent major GI haemorrhage (within 3 months)
- •Any previous cerebral bleeding episode
- •Participation in another investigational drug or device study
- •Patient unable to give consent
- •Clinical decision precluding the use of stents
研究组 & 干预措施
Conservative Arm- Medical therapy
Medical therapy
干预措施: Conservative Arm (Drug)
Invasive Arm-angiogram with PCI or CABG
same medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate
干预措施: Invasive Arm (Procedure)
结局指标
主要结局
Death
时间窗: 1 year
The cause of death will be adjudicated as being due to cardiovascular causes, non cardiovascular causes, or undetermined causes. * Cardiovascular Death includes sudden cardiac death, death due to acute myocardial infarction, death due to heart failure or cardiogenic shock, death due to stroke or death due to other cardiovascular causes * Non-Cardiovascular Death is defined as any death not covered by cardiac death or vascular death. * Undetermined cause of death refers to a death not attributable to one of the above categories of cardiovascular death or to a non-cardiovascular cause. N.B For this trial all deaths with undetermined causes will be included in the cardiovascular category.
non-fatal myocardial infarction
时间窗: 1 year
The ESC/ACC (European Society of Cardiology and the American College of Cardiology) definition of myocardial infarction will be applied, including the special circumstances of same admission myocardial re-infarction, or myocardial infarction peri-PCI.
次要结局
- Major bleeding(1 year)
- Deterioration of renal function during hospital admission(During index admission)
- In-hospital major complications(At 3, 6 and 12 months and at 2,3 and 4)
- Unplanned revascularisation(1 years)
- Permanent Stroke(1 year)
- Angina symptoms (3 months; 1yr)(3 months and 1 year)
- All cause mortality(2,3 and 4 year)
- Hospital readmission for ACS/STEMI(At 3, 6 and 12 months and at 2,3 and 4 years)
- Stent thrombosis(1 year)
研究者
Adam de Belder
Consultant Cardiologist
Brighton and Sussex University Hospitals NHS Trust