EUCTR2018-000644-26-GB进行中（未招募）1 期
Aspirin To Target Arterial events in Chronic Kidney Disease - Aspirin To Target Arterial Events In Chronic Kidney Disease (ATTACK)
niversity of Southampton0 个研究点目标入组 25,210 人开始时间: 2019年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25,210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females aged 18 years and over at the date of screening
- •2. Subjects with diagnosed CKD, defined by:
- •a) estimated GFR <60mL/min/1.73m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR (at least two test results with eGFR <60mL/min/1.73m2 at least 90 days apart with no values =60mL/min/1.73m2 in the intervening period)
- •b) ACR =3mg/mmol (at least two test results in this range at least 90 days apart with no values <3mg/mmol in the intervening period). Where no historical (within the last four years) results of ACR are available, patients with a screening ACR >3mg/mmol who have a PCR =15mg/mmol at least 90 days before with no values of PCR <15mg/mmol in the intervening period will be eligible. Where there are no historical (within the last four years) ACR or PCR results, patients with a screening ACR >3mg/mmol who have +protein or greater on a reagent strip at least 90 days before with no reagent strip results showing negative or trace protein in the intervening period will be eligible
- •3. Subjects 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. Subjects willing to be contacted and interviewed by trial investigators should the need arise for adverse event assessment
- •5. Subjects 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18000
排除标准
- •1. Subjects with CKD GFR category 5
- •2. Subjects with pre-existing CVD: angina, MI, stroke (ischaemic and haemorrhagic [intracerebral/subarachnoid]), TIA, significant peripheral vascular disease, coronary or peripheral revascularisation for atherosclerotic disease; aortic aneurysm is not an exclusion criterion
- •3. Subjects with a pre-existing condition associated with increased risk of bleeding other than CKD: upper GI bleed or peptic ulcer in the previous five years, lower GI bleed in previous twelve months, active chronic liver disease (such as cirrhosis), bleeding diathesis (investigator opinion)
- •4. Subjects taking over the counter aspirin continuously
- •5. Subjects currently prescribed anticoagulant or antiplatelet agent, including:
- •acenocoumarol, phenindione, warfarin
- •apixaban, edoxaban, rivaroxaban
- •argatroban, bivalirudin, dabigatran
- •aspirin, cangrelor, selexipag, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, abciximab, eptifibatide, tirofiban, epoprostenol, iloprost
- •unfractionated heparin, dalteparin, enoxaparin, tinzaparin
- •danaparoid, fondaparinux
- •6. Subjects who are currently and regularly taking other drugs with a potentially serious interaction with low-dose aspirin, including:
- •non-steroidal anti-inflammatories (except topical preparations), including: aceclofenac, acemetacin, brcelecoxib, 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-esomeprazole), parecoxib, phenylbutazone, piroxicam, sulindac, tenoxicam, tiaprofenic acid, tolfenamic acid
- •selective serotonin re-uptake inhibitors: citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
- •serotonin and noradrenaline re-uptake inhibitors: duloxetine, venlafaxine
- •nicorandil
- •7. Subjects with a known allergy to aspirin or definite previous clinically important adverse reaction to aspirin
- •8. Subjects with poorly controlled hypertension, defined as average of three readings at screening visit of systolic BP =180mm Hg and/or diastolic BP =105mm Hg
- •9. Subjects with anaemia: Hb <90g/L; or Hb <100g/L with MCV =75 fL
- •10. Subjects who are pregnant or likely to become pregnant during the study period
- •11. Subjects with malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness
- •12. Subjects whose behaviour or lifestyle would render them less likely to comply with study medication (e.g. alcoholism, substance abuse, debilitating psychiatric conditions or inability to provide informed consent)
- •13. Subjects in prison
- •14. Subjects currently participating in another interventional clinical trial, or who have taken part in a trial in the last three months
研究者
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