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: 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 (Estimated): 9000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xueqing Yu; Phone Number: +86-20-83827812; Email: yuxueqing@gdph.org.cn
• Study Contact Backup: Name: Li Fan; Phone Number: +86-20-87755766-8174; Email: fanli@gdph.org.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Jianxin Wan
    • Longyan, Fujian, China, 364299
      • Recruiting
      • Shanghang County Hospital
      • Contact: Jianzhong Su
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • The First Hospital of Lanzhou University
      • Contact: Tianxi Liu
  • Guangdong
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan People's Hospital
      • Contact: Guohui Liu
      • Sub-Investigator: Yi Li
    • Dongguan, Guangdong, China, 523413
      • Recruiting
      • Dongguan Donghua Hospital
      • Contact: Xiaoyan Su
      • Principal Investigator: Xiaoyan Su
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan Eighth People's Hospital
      • Contact: Zhixiong Lin
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan Marina Bay Center Hospital
      • Contact: Houqin Xiao
    • Dongguan, Guangdong, China, 523819
      • Not yet recruiting
      • Dongguan Hospital of Integrative Traditional Chinese and Western Medicine
      • Contact: Huan Lu
    • Dongguan, Guangdong, China, 523955
      • Not yet recruiting
      • Dongguan Houjie Hospital
      • Contact: Changchang Xiao
    • Dongguan, Guangdong, China
      • Withdrawn
      • Dongguan Songshan Lake Center Hospital
    • Donghai, Guangdong, China
      • Withdrawn
      • Lufeng People's Hospital
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan Nanhai District People's Hospital
      • Contact: Fuzhang Luo
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan No.1 people's hospital
      • Contact: Yaozhong Kong
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan Second People's Hospital
      • Contact: Bo Zhang
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan Sanshui People's Hospital
      • Contact: Sinian Chen
    • Foshan, Guangdong, China, 528251
      • Recruiting
      • The Second People Hospital of Foshan Nanhai
      • Contact: Xia jiang
      • Principal Investigator: xia jiang
    • Foshan, Guangdong, China
      • Recruiting
      • Guangdong Provincial Hospital of Integrative Medicine
      • Contact: Min Zhang
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Foshan Gaoming District People's Hospital
      • Contact: Tao Feng
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • ZhuJiang Hospital of Southern Medical University
      • Contact: Haibo Long
      • Contact: Youguang Liu
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Panna Liu
      • Principal Investigator: Panna Liu
    • Guangzhou, Guangdong, China
      • Recruiting
      • The third affiliated hospital of Sun Yat-Sen University
      • Contact: Hui Peng
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Gangyi Chen
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Fifth Affiliated Hospital of Guangzhou Medical University
      • Contact: Jie Xiao
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Zongpei Jiang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou First People's Hospital
      • Contact: Shuguang Qin
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Agricultural Reclamation Central Hospital
      • Contact: Jiping Wang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial Peoples Hospital
      • Contact: Xueqing Yu
      • Principal Investigator: Xueqing Yu
    • Guangzhou, Guangdong, China
      • Recruiting
      • Hua Du District People's Hospital of Guangzhou
      • Contact: Yunfang Zhang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Panyu District people's hospital of Guangzhou
      • Contact: Minyan Xie
    • Guangzhou, Guangdong, China, 510235
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Qiongqiong Yang
      • Principal Investigator: Qiongqiong Yang
    • Guangzhou, Guangdong, China, 225200
      • Recruiting
      • The Third Affiliated Hospital of Southern Medical University
      • Contact: Ying Tang
      • Principal Investigator: Ying Tang
    • Guangzhou, Guangdong, China, 510240
      • Recruiting
      • Guangzhou Redcross Hospital
      • Contact: Yan Liu
      • Principal Investigator: Yan Liu
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangdong Medical University
      • Contact: Huafeng Liu
      • Principal Investigator: Huafeng Liu
    • Guangzhou, Guangdong, China, 510370
      • Not yet recruiting
      • Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch (Guangzhou Charity Hospital)
      • Contact: Lixin Wang
    • Guangzhou, Guangdong, China, 510900
      • Not yet recruiting
      • The Fifth Affiliated Hospital of Southern Medical University
      • Contact: Huixin Bi
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Cliffod Hospital
      • Contact: Yanchun Wang
    • Guanzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Principal Investigator: Wei Chen
    • Heyuan, Guangdong, China
      • Recruiting
      • Heyuan People's Hospital
      • Contact: Jianteng Xie
    • Huizhou, Guangdong, China, 516001
      • Recruiting
      • Huizhou First People Hospital
      • Contact: Yanbo Teng
      • Principal Investigator: Yanbo Teng
    • Huizhou, Guangdong, China
      • Recruiting
      • Huizhou Central People's Hospital
      • Contact: Yongjun Shi
    • Jiangmen, Guangdong, China
      • Recruiting
      • Jiangmen Center Hospital
      • Contact: Qingdong Xu
    • Jiangmen, Guangdong, China, 529000
      • Recruiting
      • The People's Hospital of Jiangmen
      • Contact: Danhong Yu
    • Jieyang, Guangdong, China
      • Recruiting
      • Jieyang People's Hospital
      • Contact: Qinhua Liu
    • Kaiping, Guangdong, China
      • Recruiting
      • Kaiping Center Hospital
      • Principal Investigator: Xiaojun Tan
    • Lianjiang, Guangdong, China
      • Recruiting
      • Lianjiang People's Hospital
      • Contact: Wei Chen
    • Lianping, Guangdong, China, 517100
      • Not yet recruiting
      • Lianping County People's Hospital
      • Contact: Weipeng Huang
    • Licheng, Guangdong, China
      • Recruiting
      • The Fourth Affiliated Hospital of Guangzhou Medical University
      • Contact: Jumei Xia
    • Maoming, Guangdong, China
      • Recruiting
      • Maoming Hospital of Traditional Chinese Medicine
      • Contact: Chaohui Wen
    • Maoming, Guangdong, China
      • Recruiting
      • Maoming People's Hospital
      • Contact: Yeming Lu
    • Meizhou, Guangdong, China, 514011
      • Recruiting
      • Meizhou People's hospital
      • Contact: Xinghua Zhu
      • Principal Investigator: Xinghua Zhu
    • Meizhou, Guangdong, China, 514799
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital
      • Contact: Zhibo Liao
      • Principal Investigator: Zhibo Liao
    • Puning, Guangdong, China
      • Recruiting
      • Puning People's Hospital
      • Contact: Muqun Shen
    • Qingyuan, Guangdong, China, 511518
      • Recruiting
      • Qingyuan People's Hospital
      • Contact: Zhiqiang Xue
      • Principal Investigator: Zhiqiang Xue
    • Qingyuan, Guangdong, China, 511600
      • Recruiting
      • Fogang People Hospital
      • Contact: Youhe Li
      • Principal Investigator: Youhe Li
    • Qingyuan, Guangdong, China
      • Recruiting
      • Qingyuan Hospital of Traditional Chinese Medicine
      • Contact: Huaiyuan Mao
    • Shantou, Guangdong, China, 515041
      • Recruiting
      • The first Affiliated Hospital of Shantou Medical University
      • Contact: Yanqiang Peng
      • Principal Investigator: Yanqiang Peng
    • Shantou, Guangdong, China, 515144
      • Recruiting
      • Shantou Chaonan Minsheng Hospital
      • Contact: Yubin Xia
      • Principal Investigator: Yubin Xia
    • Shantou, Guangdong, China, 515031
      • Withdrawn
      • The Second Affiliated Hospital Of Shantou University Medical College
    • Shanwei, Guangdong, China
      • Recruiting
      • Shanwei People's Hospital
      • Contact: Jinxiong Xu
    • Shanwei, Guangdong, China
      • Recruiting
      • Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
      • Contact: Hongbo Ye
    • Shaoguan, Guangdong, China
      • Recruiting
      • The First People's Hospital of Shaoguan
      • Contact: Bing Zhou
    • Shaoguan, Guangdong, China
      • Recruiting
      • Yuebei People's Hospital
      • Contact: Min He
    • Shaoguan, Guangdong, China, 512600
      • Recruiting
      • Wengyuan People Hospital
      • Contact: Yaoli Huang
      • Principal Investigator: Yaoli Huang
    • Shaoguan, Guangdong, China
      • Recruiting
      • Shaoguan First People's Hospital
      • Contact: Bin Zhou
    • Shenzhen, Guangdong, China, 518036
      • Recruiting
      • Peking University Shenzhen Hospital
      • Contact: Zibo Xiong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Longhua District People's Hospital
      • Contact: Mingliang Hu
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Baoan People's Hospital
      • Contact: Jihong Chen
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen No.2 people's hospital
      • Principal Investigator: Qijun Wan
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Hospital of Southern Medical University
      • Contact: Lifen Wang
    • Shenzhen, Guangdong, China, 510275
      • Recruiting
      • The Seventh Affiliated Hospital of Sun Yat-sen
      • Contact: Zhihua Zheng
      • Principal Investigator: Zhihua Zheng
    • Shenzhen, Guangdong, China
      • Recruiting
      • The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
      • Contact: Tiecheng Yang
    • Shunde, Guangdong, China
      • Recruiting
      • ShunDe Hospital Guangzhou University of Chinese Medicine
      • Contact: Mou Liang
    • Shunde, Guangdong, China
      • Recruiting
      • The Eighth Affiliated Hospital of Southern Medical University, The First People's Hospital of Shunde
      • Contact: Xianrui Dou
    • Xiongzhou, Guangdong, China, 512499
      • Recruiting
      • Nanxiong People Hospital
      • Contact: Lingjun Zeng
      • Principal Investigator: Lingjun Zeng
    • Yangjiang, Guangdong, China
      • Recruiting
      • Yangjiang People's Hospital
      • Contact: Yong Su
    • Yangjiang, Guangdong, China, 529900
      • Recruiting
      • People's Hospital of Yangdong District Yangjiang City
      • Contact: Yang Chen
    • Yangjiang, Guangdong, China
      • Recruiting
      • Yangjiang Hospital of Traditional Chinese Medicine
      • Contact: Yingchao Zhong
    • Yingcheng, Guangdong, China
      • Recruiting
      • People Hospital of Yingde City Guangdong Province
      • Contact: Chifeng Wang
    • Yunfu, Guangdong, China
      • Recruiting
      • Yunfu People's Hospital
      • Contact: Xinyuan Liao
    • Zhanjiang, Guangdong, China
      • Recruiting
      • Central People's Hospital of Zhanjiang
      • Contact: Lei Zeng
    • Zhanjiang, Guangdong, China, 524000
      • Recruiting
      • The Affiliated Hospital of Guangdong Medical University
      • Contact: Huafeng Liu
      • Principal Investigator: Jie Xiao
    • Zhaoqing, Guangdong, China
      • Recruiting
      • Zhaoqing first people's hospital
      • Contact: Jinquan Wu
      • Principal Investigator: Jinquan Wu
    • Zhaoqing, Guangdong, China, 526070
      • Not yet recruiting
      • The Third Affiliated Hospital of Sun Yat-sen University Zhaoqing Hospital
      • Contact: Hua Tang
    • Zhongshan, Guangdong, China
      • Recruiting
      • Zhongshan City People's Hospital
      • Contact: Qing Ye
      • Principal Investigator: Qing Ye
    • Zhongshan, Guangdong, China
      • Withdrawn
      • Zhongshan Traditional Chinese Hospital
    • Zhongshan, Guangdong, China
      • Recruiting
      • Zhongshan Xiaolan People's Hospital
      • Contact: Xianggeng Chi
    • Zhuhai, Guangdong, China
      • Recruiting
      • Zhuhai People's Hospital
      • Contact: Rui Zhang
    • Zhuhai, Guangdong, China
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Cheng Wang
    • Zhuhai, Guangdong, China
      • Recruiting
      • Jinwan Center Hospital of Zhuhai
      • Contact: Juan Pang
  • Guanggong
    • Shantou, Guanggong, China, 515100
      • Recruiting
      • Shantou Central Hospital
      • Contact: Liaohua Qu
      • Contact: Xucheng Li
  • Guangxi
    • Baise City, Guangxi, China
      • Recruiting
      • The Affiliated Hospital of Youjiang Ethnic Medicine College
      • Contact: Jie Wang
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Zhenhua Yang
  • Guizhou
    • Anshun, Guizhou, China, 561099
      • Recruiting
      • Anshun People Hospital
      • Contact: Xianfeng Cheng
      • Principal Investigator: Xianfeng Cheng
    • Anshun, Guizhou, China, 561000
      • Recruiting
      • China Guihang 302 Hospital
      • Contact: Yansong Xu
    • Anshun, Guizhou, China, 561000
      • Not yet recruiting
      • Anshun Xixiu District People's Hispital
      • Contact: Li Zhao
    • Guiyang, Guizhou, China
      • Withdrawn
      • Guizhou Province Peple's Hospital
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Hainan Provincial People's Hospital
      • Contact: Jiali Wei
    • Haikou, Hainan, China, 570105
      • Not yet recruiting
      • The First Affiliated Hospital of Hainan Medical University
      • Contact: Yongjun Zhu
  • Henan
    • Xinyang, Henan, China
      • Recruiting
      • Xinyang Central Hospital
      • Contact: Bo Zhang
  • Hubei
    • Huangshi, Hubei, China, 435000
      • Not yet recruiting
      • Huangshi Central Hospital
      • Contact: Jian Chen
    • Jingmen, Hubei, China, 448001
      • Not yet recruiting
      • Jingmen Central Hospital
    • Jingzhou, Hubei, China, 434020
      • Not yet recruiting
      • Jingzhou Central Hospital
      • Contact: Yuan Tian
    • Wuhan, Hubei, China
      • Recruiting
      • The Central Hospital of Wuhan
      • Contact: Wenli Chen
    • Wuhan, Hubei, China
      • Recruiting
      • The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Chun Zhang
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University
      • Contact: Gang Xu
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan No.1 People's Hospital
      • Contact: Yanmin Zhang
    • Wuhan, Hubei, China
      • Withdrawn
      • Yichang Central People's Hospital
    • Wuhan, Hubei, China
      • Withdrawn
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China, 430012
      • Not yet recruiting
      • Wuhan Puren Hospital
      • Contact: Xiaotie Tang
    • Wuhan, Hubei, China, 430200
      • Not yet recruiting
      • The First People's Hospital of Jiangxia District, Wuhan City
      • Contact: Caixia Song
    • Xiangyang, Hubei, China, 441021
      • Recruiting
      • Xiangyang Central Hospital
      • Contact: Hai Yuan
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial People's Hospital
      • Contact: Yumei Liang
    • Changsha, Hunan, China
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Contact: Hao Zhang
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Xiangcheng Xiao
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • Withdrawn
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Nantong, Jiangsu, China, 226199
      • Recruiting
      • Nantong Haimen People's Hospital
      • Contact: Weidong Yuan
    • Xuzhou, Jiangsu, China, 221006
      • Not yet recruiting
      • Xuzhou Mining Group General Hospital
      • Contact: Xinglei Zhou
    • Yangzhou, Jiangsu, China, 225001
      • Recruiting
      • Subei People's Hospital
      • Contact: Guangyu Bi
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Recruiting
      • Ganzhou People's Hospital
      • Contact: Hongxia Peng
    • Ganzhou, Jiangxi, China, 341000
      • Recruiting
      • Ganzhou Municiple Hospital
      • Contact: Zhuo Li
      • Principal Investigator: Zhuo Li
    • Jiujiang, Jiangxi, China
      • Recruiting
      • Jiujiang No.1people's Hospital
      • Contact: Xiaoran Feng
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Qinkai Chen
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Province Peple's Hospital
      • Contact: Aimin Zhong
  • Ningxia
    • Yinchuan, Ningxia, China
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Menghua Chen
  • Shandong
    • Qingdao, Shandong, China
      • Withdrawn
      • The Affiliated Hospital Of Qingdao University
  • Shanxi
    • Xi’an, Shanxi, China, 710004
      • Recruiting
      • The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
      • Contact: Rongguo Fu
    • Xi’an, Shanxi, China
      • Withdrawn
      • The First Affiliated Hospital of Air Force Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Province People's Hospital
      • Contact: Li Wang
  • Xinjiang
    • Kashgar, Xinjiang, China, 844399
      • Recruiting
      • Jiashi County People's Hospital
      • Contact: Minfeng Liang
    • Kashgar, Xinjiang, China
      • Recruiting
      • The First People's Hospital of Kashi Prefecture
      • Contact: Shanshan Zhou
    • Kashgar, Xinjiang, China
      • Recruiting
      • The Second People's Hospital of Kashi Prefecture
      • Contact: Jie Guo
    • Kashgar, Xinjiang, China, 844700
      • Recruiting
      • Shache County People's Hospital
      • Contact: Yuxia Zhong
    • Shihezi, Xinjiang, China
      • Recruiting
      • The First Affiliated Hospital of Shihezi University Medical College
      • Contact: Xiaoping Yang
    • Ürümqi, Xinjiang, China
      • Withdrawn
      • The First Affiliated Hospital of Xinjiang Medical University
    • Ürümqi, Xinjiang, China
      • Withdrawn
      • The People's hospital of Xinjiang Uygur Autonomous Region
  • Yunnan
    • Lincang, Yunnan, China
      • Recruiting
      • Fengqing People's Hospital of Yunnan Province
      • Contact: Jinfeng Guo
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University
      • Contact: Jianghua Chen
    • Lishui, Zhejiang, China, 323020
      • Not yet recruiting
      • Lishui City Center Hospital
      • Contact: Lie Jin
    • Zhoushan, Zhejiang, China, 316100
      • Recruiting
      • 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 1, 2026
• Study Completion (Estimated): December 1, 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 (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: August 1, 2025

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