CKD (Chronic Kidney Disease) Stage 5DPhase 4NCT04381143
ASPIrin in Reducing Events in Dialysis ( ASPIRED )
A Phase 4 study testing Aspirin 100 mg Oral Tablet in people with CKD (Chronic Kidney Disease) Stage 5D, run by Guangdong Provincial People's Hospital at 127 sites in China.
Trial summary
People with kidney failure requiring dialysis have a much higher risk of developing cardiovascular (CV) disease compared with the general population. A cardiac cause accounts for 58% of all deaths in patients with end stage kidney disease (ESKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD (Chronic Kidney Disease) Stage 5D
- What is being tested?
- Aspirin 100 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,082 participants
- Where
- 127 sitesChina
- Study dates
- 30 Jul 2020to 31 Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incident or prevalent adults (≥18 years old) dialysis patients are included in the Dialysis Registry.
- Commenced on dialysis with the expectation of ongoing maintenance dialysis requirement.
- Willing and able to provide informed consent for this study.
Who cannot join
- Requirement for any form of antiplatelet agent (aspirin, glycoprotein IIb/IIIa inhibitors etc), or oral anticoagulation (warfarin, NOACs), in the view of the treating physician.
- Contraindication to aspirin, in the view of the treating physician.
- Dialysis requirement due to acute kidney injure with expectation of kidney function recovery.
- History of haemorrhagic stroke or intracranial bleed within 12 months of screening.
- Coagulopathy from any cause.
- Unable to provide informed consent.
Trial locations and contacts
127 sites in 1 country.
127 sites in 1 country
China127 sites
Anshun Xixiu District People's Hispital
Anshun, Guizhou, 561000
China Guihang 302 Hospital
Anshun, Guizhou, 561000
Anshun People Hospital
Anshun, Guizhou, 561099
The Affiliated Hospital of Youjiang Ethnic Medicine College
Baise City, Guangxi
Hunan Provincial People's Hospital
Changsha, Hunan
The third Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
Sichuan Province People's Hospital
Chengdu, Sichuan
Dongguan Donghua Hospital
Dongguan, Guangdong, 523413
Dongguan Hospital of Integrative Traditional Chinese and Western Medicine
Dongguan, Guangdong, 523819
Dongguan Houjie Hospital
Dongguan, Guangdong, 523955
Dongguan Eighth People's Hospital
Dongguan, Guangdong
Dongguan Marina Bay Center Hospital
Dongguan, Guangdong
Dongguan People's Hospital
Dongguan, Guangdong
Foshan Gaoming District People's Hospital
Foshan, Guangdong, 528000
The Second People Hospital of Foshan Nanhai
Foshan, Guangdong, 528251
Foshan Nanhai District People's Hospital
Foshan, Guangdong
Foshan No.1 people's hospital
Foshan, Guangdong
Foshan Sanshui People's Hospital
Foshan, Guangdong
Foshan Second People's Hospital
Foshan, Guangdong
Guangdong Provincial Hospital of Integrative Medicine
Foshan, Guangdong
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Ganzhou Municiple Hospital
Ganzhou, Jiangxi, 341000
Ganzhou People's Hospital
Ganzhou, Jiangxi
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 225200
The First Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, 510120
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510235
Guangzhou Redcross Hospital
Guangzhou, Guangdong, 510240
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch (Guangzhou Charity Hospital)
Guangzhou, Guangdong, 510370
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
The Fifth Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510900
Guangdong Agricultural Reclamation Central Hospital
Guangzhou, Guangdong
Guangdong Cliffod Hospital
Guangzhou, Guangdong
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong
Guangzhou First People's Hospital
Guangzhou, Guangdong
Hua Du District People's Hospital of Guangzhou
Guangzhou, Guangdong
Panyu District people's hospital of Guangzhou
Guangzhou, Guangdong
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
The Sixth Affiliated Hospital of Sun yat-sen University
Guangzhou, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570105
Hainan Provincial People's Hospital
Haikou, Hainan
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
Heyuan People's Hospital
Heyuan, Guangdong
Huangshi Central Hospital
Huangshi, Hubei, 435000
Huizhou First People Hospital
Huizhou, Guangdong, 516001
Huizhou Central People's Hospital
Huizhou, Guangdong
The People's Hospital of Jiangmen
Jiangmen, Guangdong, 529000
Jiangmen Center hospital
Jiangmen, Guangdong
Jieyang People's Hospital
Jieyang, Guangdong
Jingmen Central Hospital
Jingmen, Hubei, 448001
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Jiujiang No.1people's Hospital
Jiujiang, Jiangxi
Kaiping Center Hospital
Kaiping, Guangdong
Jiashi County People's Hospital
Kashgar, Xinjiang, 844399
Shache County People's Hospital
Kashgar, Xinjiang, 844700
The First People's Hospital of Kashi Prefecture
Kashgar, Xinjiang
The Second People's Hospital of Kashi Prefecture
Kashgar, Xinjiang
The First Hospital of Lanzhou University
Lanzhou, Gansu
Lianjiang People's Hospital
Lianjiang, Guangdong
Lianping County People's Hospital
Lianping, Guangdong, 517100
The Fourth Affiliated Hospital of Guangzhou Medical University
Licheng, Guangdong
Fengqing People's Hospital of Yunnan Province
Lincang, Yunnan
Lishui City Center Hospital
Lishui, Zhejiang, 323020
Shanghang County Hospital
Longyan, Fujian, 364299
Maoming Hospital of Traditional Chinese Medicine
Maoming, Guangdong
Maoming People's Hospital
Maoming, Guangdong
Meizhou People's Hospital
Meizhou, Guangdong, 514011
The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital
Meizhou, Guangdong, 514799
Jiangxi Province Peple's Hospital
Nanchang, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The first affiliated hospital of Guangxi Medical University
Nanning, Guangxi
Nantong Haimen People's Hospital
Nantong, Jiangsu, 226199
Puning People's Hospital
Puning, Guangdong
Qingyuan People's Hospital
Qingyuan, Guangdong, 511518
Fogang People Hospital
Qingyuan, Guangdong, 511600
Qingyuan Hospital of Traditional Chinese Medicine
Qingyuan, Guangdong
The first Affiliated Hospital of Shantou Medical University
Shantou, Guangdong, 515041
Shantou Chaonan Minsheng Hospital
Shantou, Guangdong, 515144
Shantou Central Hospital
Shantou, Guanggong, 515100
Shanwei People's Hospital
Shanwei, Guangdong
Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
Shanwei, Guangdong
Wengyuan People Hospital
Shaoguan, Guangdong, 512600
Shaoguan First People's Hospital
Shaoguan, Guangdong
The First People's Hospital of Shaoguan
Shaoguan, Guangdong
Yuebei People's Hospital
Shaoguan, Guangdong
The Seventh Affiliated Hospital of Sun Yat-sen
Shenzhen, Guangdong, 510275
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Shenzhen Baoan People's Hospital
Shenzhen, Guangdong
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong
Shenzhen Longhua District People's Hospital
Shenzhen, Guangdong
Shenzhen No.2 people's hospital
Shenzhen, Guangdong
The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
Shenzhen, Guangdong
The First Affiliated Hospital of Shihezi University Medical College
Shihezi, Xinjiang
ShunDe Hospital Guangzhou University of Chinese Medicine
Shunde, Guangdong
The Eighth Affiliated Hospital of Southern Medical University, The First People's Hospital of Shunde
Shunde, Guangdong
Wuhan Puren Hospital
Wuhan, Hubei, 430012
The First People's Hospital of Jiangxia District, Wuhan City
Wuhan, Hubei, 430200
The Central Hospital of Wuhan
Wuhan, Hubei
The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University
Wuhan, Hubei
Wuhan No.1 People's Hospital
Wuhan, Hubei
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, 710004
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Xinyang Central Hospital
Xinyang, Henan
Nanxiong People Hospital
Xiongzhou, Guangdong, 512499
Xuzhou Mining Group General Hospital
Xuzhou, Jiangsu, 221006
People's Hospital of Yangdong District Yangjiang City
Yangjiang, Guangdong, 529900
Yangjiang Hospital of Traditional Chinese Medicine
Yangjiang, Guangdong
Yangjiang People's Hospital
Yangjiang, Guangdong
Subei People's Hospital
Yangzhou, Jiangsu, 225001
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
People Hospital of Yingde City Guangdong Province
Yingcheng, Guangdong
Yunfu People's Hospital
Yunfu, Guangdong
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Zhaoqing Hospital
Zhaoqing, Guangdong, 526070
Zhaoqing first people's hospital
Zhaoqing, Guangdong
Zhongshan City People's Hospital
Zhongshan, Guangdong
Zhongshan Xiaolan People's Hospital
Zhongshan, Guangdong
Zhoushan Hospital
Zhoushan, Zhejiang, 316100
Jinwan Center Hospital of Zhuhai
Zhuhai, Guangdong
The fifth affiliated hospital of sun yat-sen university
Zhuhai, Guangdong
Zhuhai People's Hospital
Zhuhai, Guangdong
About this study
Official title: ASPIrin in Reducing Events in Dialysis
People with kidney failure requiring dialysis have a much higher risk of developing cardiovascular (CV) disease compared with the general population. A cardiac cause accounts for 58% of all deaths in patients with end stage kidney disease (ESKD). At the same time, this population has increased risks of clotting as well as bleeding episodes. While aspirin is known to reduce cardiovascular complications in the general population, evidence to support the use of aspirin in people with ESKD receiving dialysis therapy is currently lacking. The ASPIrin to Reduce Event in Dialysis (ASPIRED) trial will test whether aspirin use in dialysis patients safely improves outcomes compared with no aspirin use.
Read the detailed description
ASPIRED is an investigator-initiated, multi-center, double-blind, parallel group, event-driven, pragmatic, registry-based randomized controlled trial that will define the value of low dose aspirin (100 mg daily) on cardiovascular events in people with ESKD receiving dialysis.
The study will be conducted using the existing platform of the Chinese peritoneal dialysis (PD) and hemodialysis (HD) Dialysis Registry to screen, recruit and to collect study data as part of patient's routine clinical care during dialysis to improve efficiency and to minimize cost of a clinical trial.
ASPIRED is an event driven trial with an anticipated duration of approximately 5 years.
Randomization will be performed using a web-based system via a pass word protected encrypted website interface.
The study procedure utilizes routine six-monthly clinic visits for study follow-up to increase efficiency and minimize the burden on participants.
The analysis will be based on intention-to-treat principles. An independent Data Safety and Monitoring Board (DSMB) will established to monitor the study for safety and efficacy.
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D
- Being tested
- Aspirin 100 mg Oral Tablet, Matching Placebo
- Keywords
- Aspirin, Dialysis, End Stage Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 100 mg Oral TabletDrug
Aspirin 100 mg tablet daily
Matching PlaceboDrug
Matching Placebo 1 pill daily
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Aspirin tablet 100mg daily Receives: Drug: Aspirin 100 mg Oral Tablet |
| Matching Placebo | Placebo comparator | Placebo tablet 1 pill daily Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with composite of major cardiovascular events (3-point MACE)
A composite of cardiovascular death, myocardial infarction, or ischemic stroke.
Measured: From trial initiation to any event first occurrence, up to 5 years.
Secondary outcomes (11)
Number of Participants with composite of major cardiovascular events plus all-cause death
A composite of cardiovascular death, myocardial infarction, ischemic stroke or all-cause death.
Measured: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with composite of major cardiovascular events, hospitalised unstable angina (UA) and hospitalised transient ischaemic attack (TIA)
A composite of cardiovascular death, myocardial infarction, ischemic stroke, hospitalised unstable angina (UA) or hospitalised transient ischaemic attack (TIA)
Measured: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with cardiovascular death
Death due to CV cause.
Measured: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with Myocardial infarction
Measured: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with ischemic stroke
Measured: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with all-cause death
Death for any reason.
Measured: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with coronary revascularization
Measured: From trial initiation to any event occurrence, up to 5 years.
Number of Participants with fistula or graft thrombosis
Measured: From trial initiation to any event occurrence, up to 5 years.
Number of Participants with intracranial haemorrhage
Measured: From trial initiation to any event occurrence, up to 5 years.
Number of Participants with peripheral vascular events
Measured: From trial initiation to any event occurrence, up to 5 years.
Number of Participants with ischemic events
Defined as a composite of myocardial infarction (MI), coronary death, ischemic stroke, or any revascularization procedure (i.e, exclusion of noncoronary cardiac deaths and strokes confirmed to be haemorrhagic).
Measured: From trial initiation to any event occurrence, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start30 Jul 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD (Chronic Kidney Disease) Stage 5DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic designs
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The George Institute
- Responsible party
- Sponsor
- Investigators
- Xueqing Yu, Study chair, Guangdong Provincial People's HospitalVlado Perkovic, Study chair, The University of New South Wales SydneyMuh Geot Wong, Study director, The George InstituteWei Chen, Study director, First Affiliated Hospital, Sun Yat-Sen UniversityLi Fan, Study director, Guangdong Provincial People's HospitalZhiming Ye, Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381143
- Sponsor's protocol ID
- GDPH-CH-2774
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data that supports the results will be shared following publication. Any sub-study analysis and publication will have to be reviewed and approved by the Trial Steering Committee, local Ethics and Regulatory requirements.