ISRCTN40920200进行中（未招募）4 期
ATTACK: Aspirin To Target Arterial events in Chronic Kidney disease
niversity of Southampton0 个研究点目标入组 4,633 人开始时间: 2018年10月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,633
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35449015/ (added 25/04/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 20/03/2024:
- •1. Males and females aged 18 years and over at the date of screening
- •2. Subjects with CKD (reduced eGFR and/or albuminuria) defined as:
- •2.1. Estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2 for at least 90 days, and/or
- •2.2. Kidney disease code on the GP electronic patient AND most recent eGFR in CKD-defining range (<60mL/min/1.73m2), and/or
- •2.3. 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)
- •3. Subjects who are willing to give permission for their paper and electronic medical records to be accessed by trial investigators
- •4. Subjects who are willing to be contacted and interviewed by trial investigators
- •5. Subjects who can communicate well with the investigator or designee, understand the requirements of the study and understand and sign the written informed consent
- •Previous inclusion criteria as of 11/01/2021:
- •1. Aged 18 years or over at the date of screening
- •2. Subjects with CKD, defined by at least one of the following:
- •2.1. Decreased estimated glomerular filtration rate [eGFR] for at least 90 days (defined as eGFR <60mL/min/1.73m2), and/or
- •2.2. Albuminuria or (where there are no measurements of albuminuria) proteinuria for at least 90 days (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 [and in all cases where the most recent qualifying result is ACR =3mg/mmol or PCR =15mg/mmol]), and/or
- •2.3. CKD formally diagnosed/coded on the GP electronic patient AND most recent quantitative tests within last 15 months and in CKD-defining range (eGFR <60mL/min/1.73m2 and/or ACR =3mg/mmol, and/or PCR =15mg/mmol)
- •3. Willing to give permission for their paper and electronic medical records to be accessed and abstracted by trial investigators for the duration of the trial
- •4. Willing to be contacted and interviewed by trial investigators should the need arise for adverse event assessment
- •5. Able to communicate well with the investigator or designee, to understand and comply with the requirements of the study and to understand and sign the written informed consent
- •Previous participant inclusion criteria as of 08/01/2021:
- •1. Aged 18 years or over at the date of screening
- •2. Diagnosed with CKD, defined by at least one of the following:
- •2.1. Decreased estimated glomerular filtration rate (eGFR) for at least 90 days (defined as eGFR <60 ml/min/1.73m²)
- •2.2. Albuminuria or, where there are no measurements of albuminuria, proteinuria for at least 90 days (defined as the most recent qualifying result is ACR =3 mg/mmol or PCR =15 mg/mmol, and at least one of the following: urine albumin:creatinine ratio [ACR] =3 mg/mmol, and/or urine protein:creatinine ratio [PCR] =15 mg/mmol, and/or + protein or greater on reagent strip)
- •2.3. CKD formally diagnosed/coded on the GP electronic patient and most recent quantitative tests within the last 15 months in CKD-defining range (eGFR <60 ml/min/1.73m² and/or ACR =3 mg/mmol, and/or PCR =15 mg/mmol)
- •3. Willing to give permission for their paper and electronic medical records to be accessed and abstracted by trial investigators for the duration of the trial
- •4. Willing to be contacted and interviewed by trial investigators should the need arise for adverse event assessment
- •5. Able to communicate well w
排除标准
- •Current exclusion criteria as of 20/03/2024:
- •1. CKD GFR category 5
- •2. Pre-existing CVD:
- •2.1. Angina
- •2.2. Myocardial infarction
- •2.3. Stroke (ischaemic and haemorrhagic (intracerebral/subarachnoid))
- •2.4. Transient ischemic attack
- •2.5. Significant peripheral vascular disease
- •2.6. Coronary or peripheral revascularisation for atherosclerotic disease
- •3. Pre-existing condition associated with increased risk of bleeding other than CKD:
- •4. Subjects currently prescribed anticoagulants or antiplatelet agent, or taking over the counter (OTC) aspirin continuously
- •5. Currently and regularly taking other drugs with a potentially serious interaction with aspirin
- •6. Known allergy to aspirin or definite previous clinically important adverse reaction to aspirin
- •7. Poorly controlled hypertension (latest recorded systolic blood pressure =180 mmHg and/or diastolic blood pressure =105 mmHg)
- •8. Subjects with other conditions which in the opinion of their General Practitioner (GP) would preclude prescription of aspirin in routine clinical practice such as significant anaemia or thrombocytopenia
- •9. Pregnant or likely to become pregnant during the study period
- •10. Malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness
- •11. Behaviour or lifestyle would render them less likely to comply with study medication
- •13. In prison
- •14. Currently participating in another interventional clinical trial or who have taken part in a trial in the last 3 months
- •Previous participant exclusion criteria as of 08/01/2021:
- •1. CKD GFR category 5
- •2. Pre-existing CVD:
- •2.1. Angina
- •2.2. Myocardial infarction
- •2.3. Stroke (ischaemic and haemorrhagic (intracerebral/subarachnoid))
- •2.4. Transient ischemic attack
- •2.5. Significant peripheral vascular disease
- •2.6. Coronary or peripheral revascularisation for atherosclerotic disease
- •Aortic aneurysm is not an exclusion criterion
- •3. Pre-existing condition associated with increased risk of bleeding other than CKD:
- •3.1. Upper GI bleed or peptic ulcer in the previous 5 years
- •3.2. Lower GI bleed in previous 12 months
- •3.3. Active chronic liver disease (such as cirrhosis)
- •3.4. Bleeding diathesis (investigator opinion)
- •4. Taking over the counter aspirin continuously
- •5. Currently prescribed anticoagulant or antiplatelet agents, including:
- •5.1. Acenocoumarol, phenindione, warfarin
- •5.2. Pixaban, edoxaban, rivaroxaban
- •5.3. Argatroban, bivalirudin, dabigatran
- •5.4. Aspirin, cangrelor, selexipag, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, abciximab, eptifibatide, tirofiban, epoprostenol, iloprost
- •5.5. Unfractionated heparin, dalteparin, enoxaparin, tinzaparin
- •5.6. Danaparoid, fondaparinux
- •6. Currently and regularly taking other drugs with a potentially serious interaction with low-dose aspirin, including:
- •6.1. Non-steroidal anti-inflammatories (except topical preparations), including aceclofenac, acemetacin, celecoxib, dexibuprofen, dexketoprofen, diclofenac (and combination diclofenac-misoprostol preparation), etodolac, etoricoxib, felbinac, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, ketorolac trometamol, mefenamic acid, meloxicam, nabumetone, naproxen (and naproxen-esomeprazol), parecoxib, phenylbutazone, piroxicam, sulindac, tenoxicam, tiaprofenic acid, tolfenamic acid
- •6.2. Selective serotonin re-uptake inhibitors:citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
- •6.3. Serotonin and noradrenaline re-uptake inhibi
研究者
相似试验
进行中（未招募）
1 期
Aspirin to target arterial events in chronic kidney disease (ATTACK)Patients with chronic kidney disease who do not have pre-existing cardiovascular diseaseMedDRA version: 20.0Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2018-000644-26-GBniversity of Southampton25,210
进行中（未招募）
4 期
Chronotherapy with Low-dose Aspirin for Primary PreventionType 2 DiabetesNCT00725127University of Vigo3,200
终止
4 期
Comparison of Awakening Versus Bedtime Dosing of Aspirin in Pre-Hypertension or Mild Essential HypertensionHigh-Normal Blood PressureMild Essential HypertensionNCT00449618University of Vigo23
已完成
1 期
Aspirin Attenuates Inflammation in Human Cerebral AneurysmsThe Focus of the Study is to Monitor MRI Signal Changes and Inflammatory Biomarkers With Use of Aspirin in Patients With Unruptured Cerebral AneurysmNCT01710072University of Iowa11
招募中
1 期
Aspirin to prevent cardiovascular events in patients with pneumoniaPneumonia, Myocardial infarctionCTIS2023-504553-12-01Amsterdam UMC760