ASPIrin in Reducing Events in Dialysis ( ASPIRED )

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.

Study Overview

• Status: Active, not recruiting
• Conditions: CKD (Chronic Kidney Disease) Stage 5D
• Intervention / Treatment: Drug: Aspirin 100 mg Oral Tablet; Drug: Matching Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 9082
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
    • Longyan, Fujian, China, 364299
      • Shanghang County Hospital
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital
    • Dongguan, Guangdong, China, 523413
      • Dongguan Donghua Hospital
    • Dongguan, Guangdong, China, 523819
      • Dongguan Hospital of Integrative Traditional Chinese and Western Medicine
    • Dongguan, Guangdong, China, 523955
      • Dongguan Houjie Hospital
    • Dongguan, Guangdong, China
      • Dongguan Eighth People's Hospital
    • Dongguan, Guangdong, China
      • Dongguan Marina Bay Center Hospital
    • Foshan, Guangdong, China, 528000
      • Foshan Gaoming District People's Hospital
    • Foshan, Guangdong, China, 528251
      • The Second People Hospital of Foshan Nanhai
    • Foshan, Guangdong, China
      • Foshan Nanhai District People's Hospital
    • Foshan, Guangdong, China
      • Foshan No.1 people's hospital
    • Foshan, Guangdong, China
      • Foshan Sanshui People's Hospital
    • Foshan, Guangdong, China
      • Foshan Second People's Hospital
    • Foshan, Guangdong, China
      • Guangdong Provincial Hospital of Integrative Medicine
    • Guangzhou, Guangdong, China, 510630
      • The First Affiliated Hospital of Jinan University
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
    • Guangzhou, Guangdong, China
      • The Sixth Affiliated Hospital of Sun yat-sen University
    • Guangzhou, Guangdong, China
      • The Fifth Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510900
      • The Fifth Affiliated Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510235
      • Sun Yat-sen Memorial Hospital
    • Guangzhou, Guangdong, China, 225200
      • The Third Affiliated Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangdong Medical University
    • Guangzhou, Guangdong, China, 510240
      • Guangzhou Redcross Hospital
    • Guangzhou, Guangdong, China, 510370
      • Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch (Guangzhou Charity Hospital)
    • Guangzhou, Guangdong, China
      • Guangdong Agricultural Reclamation Central Hospital
    • Guangzhou, Guangdong, China
      • Guangdong Cliffod Hospital
    • Guangzhou, Guangdong, China
      • Guangdong Provincial Peoples Hospital
    • Guangzhou, Guangdong, China
      • Hua Du District People's Hospital of Guangzhou
    • Guangzhou, Guangdong, China
      • Panyu District people's hospital of Guangzhou
    • Guanzhou, Guangdong, China
      • The First Affiliated Hospital of Sun Yat-sen University
    • Heyuan, Guangdong, China
      • Heyuan People's Hospital
    • Huizhou, Guangdong, China
      • Huizhou Central People's Hospital
    • Huizhou, Guangdong, China, 516001
      • Huizhou First People Hospital
    • Jiangmen, Guangdong, China, 529000
      • The People's Hospital of Jiangmen
    • Jiangmen, Guangdong, China
      • Jiangmen Center hospital
    • Jieyang, Guangdong, China
      • Jieyang People's Hospital
    • Kaiping, Guangdong, China
      • Kaiping Center Hospital
    • Lianjiang, Guangdong, China
      • Lianjiang People's Hospital
    • Lianping, Guangdong, China, 517100
      • Lianping County People's Hospital
    • Licheng, Guangdong, China
      • The Fourth Affiliated Hospital of Guangzhou Medical University
    • Maoming, Guangdong, China
      • Maoming People's Hospital
    • Maoming, Guangdong, China
      • Maoming Hospital of Traditional Chinese Medicine
    • Meizhou, Guangdong, China, 514011
      • Meizhou People's Hospital
    • Meizhou, Guangdong, China, 514799
      • The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital
    • Puning, Guangdong, China
      • Puning People's Hospital
    • Qingyuan, Guangdong, China, 511518
      • Qingyuan People's Hospital
    • Qingyuan, Guangdong, China, 511600
      • Fogang People Hospital
    • Qingyuan, Guangdong, China
      • Qingyuan Hospital of Traditional Chinese Medicine
    • Shantou, Guangdong, China, 515041
      • The first Affiliated Hospital of Shantou Medical University
    • Shantou, Guangdong, China, 515144
      • Shantou Chaonan Minsheng Hospital
    • Shanwei, Guangdong, China
      • Shanwei People's Hospital
    • Shanwei, Guangdong, China
      • Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
    • Shaoguan, Guangdong, China
      • Yuebei People's Hospital
    • Shaoguan, Guangdong, China, 512600
      • Wengyuan People Hospital
    • Shaoguan, Guangdong, China
      • Shaoguan First People's Hospital
    • Shaoguan, Guangdong, China
      • The First People's Hospital of Shaoguan
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hospital
    • Shenzhen, Guangdong, China
      • Shenzhen Hospital of Southern Medical University
    • Shenzhen, Guangdong, China
      • Shenzhen Longhua District People's Hospital
    • Shenzhen, Guangdong, China, 510275
      • The Seventh Affiliated Hospital of Sun Yat-sen
    • Shenzhen, Guangdong, China
      • Shenzhen Baoan People's Hospital
    • Shenzhen, Guangdong, China
      • Shenzhen No.2 people's hospital
    • Shenzhen, Guangdong, China
      • The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
    • Shunde, Guangdong, China
      • ShunDe Hospital Guangzhou University of Chinese Medicine
    • Shunde, Guangdong, China
      • The Eighth Affiliated Hospital of Southern Medical University, The First People's Hospital of Shunde
    • Xiongzhou, Guangdong, China, 512499
      • Nanxiong People Hospital
    • Yangjiang, Guangdong, China, 529900
      • People's Hospital of Yangdong District Yangjiang City
    • Yangjiang, Guangdong, China
      • Yangjiang Hospital of Traditional Chinese Medicine
    • Yangjiang, Guangdong, China
      • Yangjiang People's Hospital
    • Yingcheng, Guangdong, China
      • People Hospital of Yingde City Guangdong Province
    • Yunfu, Guangdong, China
      • Yunfu People's Hospital
    • Zhanjiang, Guangdong, China
      • Central People's Hospital of Zhanjiang
    • Zhanjiang, Guangdong, China, 524000
      • The Affiliated Hospital of Guangdong Medical University
    • Zhaoqing, Guangdong, China
      • Zhaoqing first people's hospital
    • Zhaoqing, Guangdong, China, 526070
      • The Third Affiliated Hospital of Sun Yat-sen University Zhaoqing Hospital
    • Zhongshan, Guangdong, China
      • Zhongshan City People's Hospital
    • Zhongshan, Guangdong, China
      • Zhongshan Xiaolan People's Hospital
    • Zhuhai, Guangdong, China
      • Zhuhai People's Hospital
    • Zhuhai, Guangdong, China
      • The fifth affiliated hospital of sun yat-sen university
    • Zhuhai, Guangdong, China
      • Jinwan Center Hospital of Zhuhai
  • Guanggong
    • Shantou, Guanggong, China, 515100
      • Shantou Central Hospital
  • Guangxi
    • Baise City, Guangxi, China
      • The Affiliated Hospital of Youjiang Ethnic Medicine College
    • Nanning, Guangxi, China
      • The first affiliated hospital of Guangxi Medical University
  • Guizhou
    • Anshun, Guizhou, China, 561000
      • Anshun Xixiu District People's Hispital
    • Anshun, Guizhou, China, 561000
      • China Guihang 302 Hospital
    • Anshun, Guizhou, China, 561099
      • Anshun People Hospital
  • Hainan
    • Haikou, Hainan, China
      • Hainan Provincial People's Hospital
    • Haikou, Hainan, China, 570105
      • The First Affiliated Hospital of Hainan Medical University
  • Henan
    • Xinyang, Henan, China
      • Xinyang Central Hospital
  • Hubei
    • Huangshi, Hubei, China, 435000
      • Huangshi Central Hospital
    • Jingmen, Hubei, China, 448001
      • Jingmen Central Hospital
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Central Hospital
    • Wuhan, Hubei, China
      • The Central Hospital of Wuhan
    • Wuhan, Hubei, China, 430012
      • Wuhan Puren Hospital
    • Wuhan, Hubei, China, 430200
      • The First People's Hospital of Jiangxia District, Wuhan City
    • Wuhan, Hubei, China
      • The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University
    • Wuhan, Hubei, China
      • Wuhan No.1 People's Hospital
    • Xiangyang, Hubei, China, 441021
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China
      • The third Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Xiangya Hospital Central South University
    • Changsha, Hunan, China
      • Hunan Provincial People's Hospital
  • Jiangsu
    • Nantong, Jiangsu, China, 226199
      • Nantong Haimen People's Hospital
    • Xuzhou, Jiangsu, China, 221006
      • Xuzhou Mining Group General Hospital
    • Yangzhou, Jiangsu, China, 225001
      • Subei People's Hospital
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Ganzhou People's Hospital
    • Ganzhou, Jiangxi, China, 341000
      • Ganzhou Municiple Hospital
    • Jiujiang, Jiangxi, China
      • Jiujiang No.1people's Hospital
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China
      • Jiangxi Province Peple's Hospital
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shanxi
    • Xi’an, Shanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Province People's Hospital
  • Xinjiang
    • Kashgar, Xinjiang, China
      • The Second People's Hospital of Kashi Prefecture
    • Kashgar, Xinjiang, China, 844399
      • Jiashi County People's Hospital
    • Kashgar, Xinjiang, China, 844700
      • Shache County People's Hospital
    • Kashgar, Xinjiang, China
      • The First People's Hospital of Kashi Prefecture
    • Shihezi, Xinjiang, China
      • The First Affiliated Hospital of Shihezi University Medical College
  • Yunnan
    • Lincang, Yunnan, China
      • Fengqing People's Hospital of Yunnan Province
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, Zhejiang University
    • Lishui, Zhejiang, China, 323020
      • Lishui City Center Hospital
    • Zhoushan, Zhejiang, China, 316100
      • Zhoushan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Aspirin tablet 100mg daily	Drug: Aspirin 100 mg Oral Tablet; Aspirin 100 mg tablet daily
Placebo Comparator: Matching Placebo; Placebo tablet 1 pill daily	Drug: Matching Placebo; Matching Placebo 1 pill daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with composite of major cardiovascular events (3-point MACE)	A composite of cardiovascular death, myocardial infarction, or ischemic stroke.	From trial initiation to any event first occurrence, up to 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with all-cause death	Death for any reason.	From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with coronary revascularization		From trial initiation to any event occurrence, up to 5 years.
Number of Participants with fistula or graft thrombosis		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).	From trial initiation to any event 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)	From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with cardiovascular death	Death due to CV cause.	From trial initiation to any event first occurrence, up to 5 years.
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.	From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with Myocardial infarction		From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with ischemic stroke		From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with intracranial haemorrhage		From trial initiation to any event occurrence, up to 5 years.
Number of Participants with peripheral vascular events		From trial initiation to any event occurrence, up to 5 years.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	Major bleeding is defined based on modified International Society on Thrombosis and Haemostasis (ISTH) definition, including fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intra-spinal, intra-ocular, retro-peritoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, or bleeding into a surgical site requiring re-operation, and/or bleeding leading to hospitalization.	From trial initiation to any event first occurrence, up to 5 years.

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: The George Institute
• Investigators: Study Chair: Xueqing Yu, Guangdong Provincial People's Hospital; Study Director: Muh Geot Wong, The George Institute; Study Director: Wei Chen, First Affiliated Hospital, Sun Yat-Sen University; Study Director: Zhiming Ye, Guangdong Provincial People's Hospital; Study Chair: Vlado Perkovic, The University of New South Wales Sydney; Study Director: Li Fan, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Aspirin; Dialysis; End Stage Kidney Disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Salicylates; Hydroxybenzoates; Aspirin
• Other Study ID Numbers: GDPH-CH-2774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No