Aspirin to Target Arterial Events in Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4,633
- 试验地点
- 1
- 主要终点
- Number of participants with a Major vascular event: Composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage)
研究概览
简要总结
This study aims to find out whether people with chronic kidney disease [CKD] should take low dose aspirin to reduce the risk of first heart attack or stroke (cardiovascular disease [CVD]). CKD is common and is associated with an increased risk of CVD.
CVD is caused by small blood clots and aspirin thins the blood to reduce the risk of such clots developing but it also increases the risk of bleeding.
Aspirin is recommended to prevent further CVD in people who have already had a first CVD event (so called secondary prevention). Here the investigators want to study the use of aspirin as primary prevention in people with CKD who have not had a CVD to prevent the first event, to assess whether the potential benefits exceed the risks.
Eligible patients will be recruited from their United Kingdom (UK) general practices and allocated by chance to be prescribed once daily low dose aspirin or usual care only. Follow-up will be for several years both electronically (for general practice, hospital and mortality data) and by annual questionnaires to ascertain CVD and bleeding events.
详细描述
Aim To test the hypothesis that the addition of 75mg aspirin once daily to usual care reduces the risk of major vascular events in patients with chronic kidney disease (CKD) who do not have pre-existing cardiovascular disease (CVD)
Design Open label, multi-centre randomised controlled trial
Setting UK general practices
Sample size 25,210 patients (12,605 per arm). A total of 1,827 major vascular events overall are required.
Eligibility Inclusion Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Adjudication of outcomes blinded
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
- •Males and females aged 18 years and over at the date of screening
- •.Subjects with CKD (reduced eGFR and/or albuminuria) defined as: • estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2 for at least 90 days, and/or • kidney disease code on the GP electronic patient AND most recent eGFR in CKD-defining range (<60mL/min/1.73m2), and/or • albuminuria or proteinuria (defined as urine albumin:creatinine ratio [ACR] ≥3mg/mmol, and/or urine protein:creatinine ratio [PCR] ≥15mg/mmol, and/or +protein or greater on reagent strip)
- •Subjects who are willing to give permission for their paper and electronic medical records to be accessed by trial investigators
- •Subjects who are willing to be contacted and interviewed by trial investigators
- •Subjects who can communicate well with the investigator or designee, understand the requirements of the study and understand and sign the written informed consent
排除标准
- •Subjects with CKD GFR category 5
- •Subjects with pre-existing cardiovascular disease (angina, myocardial infarction, stroke, transient ischaemic attack (TIA), significant peripheral vascular disease, coronary or peripheral revascularisation for atherosclerotic disease)
- •Subjects with a current pre-existing condition associated with increased risk of bleeding other than CKD
- •Subjects currently prescribed anticoagulants or antiplatelet agent, or taking over the counter (OTC) aspirin continuously
- •Subjects who are currently and regularly taking other drugs with a potentially serious interaction with aspirin
- •Subjects with a known allergy to aspirin or definite previous clinically important adverse reaction
- •Subjects with poorly controlled hypertension (systolic blood pressure [BP] ≥180 mmHg and/or diastolic BP ≥105 mmHg)
- •. Subjects with other conditions which in the opinion of their General Practitioner (GP) would preclude prescription of aspirin in routine clinical practice, for example significant anaemia or thrombocytopenia
- •Subjects who are pregnant or likely to become pregnant during the study period
- •Subjects with malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness
- •Subjects whose behaviour or lifestyle would render them less likely to comply with study medication
- •Subjects in prison
- •Subjects currently participating in another clinical trial of an investigational medicinal product or who have taken part in such a trial in the last three months (Covid-19 vaccine studies are acceptable)
研究组 & 干预措施
Aspirin
75mg of non enteric coated or dispersible aspirin once daily added to usual medications
干预措施: Aspirin (Drug)
结局指标
主要结局
Number of participants with a Major vascular event: Composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage)
时间窗: Over average 4 years follow-up
Acute MI defined according to the Third Universal Definition of myocardial infarction (MI). Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke (fatal and non-fatal) including intracerebral haemorrhage and SAH which has been confirmed on appropriate imaging is excluded from the primary composite endpoint and included within the secondary endpoints.
次要结局
- Number of participants dying from any cause(Average 4 years follow-up)
- Number of participants with Non-fatal myocardial infarction(Average 4 years follow-up)
- Health-related quality of life, mean utility score(Average 4 years follow-up)
- Number of participants with major vascular events plus revascularisation(Average 4 years follow-up)
- Number of participants with Clinically relevant non major bleeding (hospitalised)(Average 4 years follow-up)
- Number of participants with Cardiovascular death(Average 4 years follow-up)
- Number of participants with intra-cranial haemorrhage, fatal and non fatal major extra cranial haemorrhage(Average 4 years follow-up)
- Number of participants with Non-fatal stroke(Average 4 years follow-up)
- Number of participants with fatal and non fatal major extra-cranial haemorrhage and clinically relevant non major bleed (if hospitalised)(Average 4 years follow-up)
- Number of participants with Fatal and non-fatal intra-cranial haemorrhage(Average 4 years follow-up)
- Number of participants with Fatal and non-fatal major extra-cranial haemorrhage(Average 4 years follow-up)