ACTRN12613000349741已完成4 期
The AspiriN To Inhibit SEPSIS (ANTISEPSIS) trial; an ASPirin in Preventing Events in the Elderly, (ASPREE) Substudy to measure the benefit of low dose aspirin in the prevention of severe sepsis in the elderly.
ational Health and Medical Research Council0 个研究点目标入组 17,000 人开始时间: 2013年4月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 70 Years 至 o limit（—）
- 性别
- All
入选标准
- •AS PER ASPREE STUDY
- •Non-institutionalised
- •Willing and able to provide informed consent, and willing to accept the study
- •requirements
- •Physically capable of regularly attending his/her family physician.
- •Without major cardiovascular disease, dementia or other exclusion criteria, as
- •listed below.
排除标准
- •AS PER ASPREE STUDY
- •A history of a diagnosed cardiovascular event defined as MI, heart failure, peripheral arterial disease, angina pectoris, stroke, transient ischemic attack, >50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, coronary artery bypass grafting, or abdominal aortic aneurysm.
- •A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease.
- •A current or recurrent condition with a high risk of major bleeding, e.g. cerebral aneurysm or cerebral AV malformation, any bleeding diathesis, gastrointestinal malignancy, recent peptic ulcer, liver disease, oesophageal varicosities, uremia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding.
- •Anaemia, i.e. haemoglobin level below the normal value for the gender of the participant (males: 13g/L, females: 11.5 g/L).
- •Absolute contraindication or allergy to aspirin.
- •Current participation in a clinical trial.
- •Current continuous use of aspirin or other anti-platelet drug or anticoagulant.
- •Participants with previous use may enter the trial, provided they have been off the medication for 3 months. (Concurrent use of a NSAID is not an exclusion criterion but subjects are requested to take their trial medication 30 minutes prior to other medications.)
- •A systolic blood pressure 180 mmHg and or a diastolic blood pressure 105mmHg
- •A history of a clinical diagnosis of diabetes (glucose 7.0 mmol/L (fasting) or 11.1 mmol/L (non fasting) )
- •A history of dementia or a Modified Mini-Mental State Examination (3MS) score 77 as measured at Visit 1: Lifestyle Profile and Screening.
- •An inability to perform independently, or more than ‘A little difficulty’ reported in performing, any one of the 6 Katz ADLs.
- •Pill-taking compliance outside the range of 80-120% during the placebo run-in phase.
研究者
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