Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of participants with major adverse cardiac and cerebral events (the composite of death, myocardial infarction, urgent revascularisation, recurrent hospitalization due to cardiac reason and stroke).
研究概览
简要总结
A multicenter, randomized clinical trial in elderly patients (over 80 years old) with unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).
A total of 200 patients will be randomized to medical treatment (100 patients) or coronary angiography with revascularization if feasible (100 patients). Information regarding prior history, frailty, clinical presentation, in-hospital events, complications, angina, quality of life and mortality will be collected. Follow up time is 1 year.
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
- •>80 years of age
- •Acute coronary syndrome with ischemic symptoms (mainly chest pain) lasting over 10 minutes during the last 72 hours.
- •AND at least one of the following:
- •ST-segment depression on ECG > 1mm
- •Elevated cardiac troponins
- •Written informed consent before randomization
排除标准
- •Percutaneous coronary intervention (PCI) within 30 days prior to randomization
- •Suspected ongoing active internal bleeding
- •ST segment elevation of >1mm in two contiguous leads on ECG
- •Enrollment in another study that has not completed the follow up phase.
- •Known allergy to aspirin or clopidogrel
- •Severe dementia
- •Expected limited 1 year survival due to other disease(s)
- •Unwillingness to participate in the trial or expected problems with compliance
研究组 & 干预措施
Conservative therapy
Optimized medical therapy
Invasive therapy
Coronary angiography and revascularization if feasible
干预措施: Coronary angiography and revascularization if feasible (Procedure)
结局指标
主要结局
Number of participants with major adverse cardiac and cerebral events (the composite of death, myocardial infarction, urgent revascularisation, recurrent hospitalization due to cardiac reason and stroke).
时间窗: 1 year
次要结局
- Number of participants with major bleeding(1 month)
- Number of participants with major adverse cardiac or cerebral event(1 month)
- Number of participants with minor bleeding(1 month)
- Number of participants with composite of cardiac death or myocardial infarction(1 year)
- Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months(1 year)
- Change from baseline of participants level of angina pectoris at 12 months(12 months)
- Number of participants dead (all cause mortality)(1 year)
研究者
Per Albertsson
Head of Cardiology
Sahlgrenska University Hospital, Sweden