NCT04381143

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,000

participants targeted

Target at P75+ for phase_4

Timeline
7mo left

Started Jul 2020

Longer than P75 for phase_4

Geographic Reach
1 country

139 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2020Dec 2026

First Submitted

Initial submission to the registry

April 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 18, 2025

Status Verified

August 1, 2025

Enrollment Period

6.1 years

First QC Date

April 23, 2020

Last Update Submit

November 14, 2025

Conditions

Keywords

AspirinDialysisEnd Stage Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Number of Participants with composite of major cardiovascular events plus all-cause death

    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)

    From trial initiation to any event first occurrence, up to 5 years.

  • Number of Participants with cardiovascular 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.

  • +6 more secondary outcomes

Other Outcomes (1)

  • Major bleeding

    From trial initiation to any event first occurrence, up to 5 years.

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin tablet 100mg daily

Drug: Aspirin 100 mg Oral Tablet

Matching Placebo

PLACEBO COMPARATOR

Placebo tablet 1 pill daily

Drug: Matching Placebo

Interventions

Aspirin 100 mg tablet daily

Aspirin

Matching Placebo 1 pill daily

Matching Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (139)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Shanghang County Hospital

Longyan, Fujian, 364299, China

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

Dongguan Donghua Hospital

Dongguan, Guangdong, 523413, China

RECRUITING

Dongguan Hospital of Integrative Traditional Chinese and Western Medicine

Dongguan, Guangdong, 523819, China

NOT YET RECRUITING

Dongguan Houjie Hospital

Dongguan, Guangdong, 523955, China

NOT YET RECRUITING

Dongguan Eighth People's Hospital

Dongguan, Guangdong, China

RECRUITING

Dongguan Marina Bay Center Hospital

Dongguan, Guangdong, China

RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, China

RECRUITING

Dongguan Songshan Lake Center Hospital

Dongguan, Guangdong, China

WITHDRAWN

Lufeng People's Hospital

Donghai, Guangdong, China

WITHDRAWN

Foshan Gaoming District People's Hospital

Foshan, Guangdong, 528000, China

RECRUITING

The Second People Hospital of Foshan Nanhai

Foshan, Guangdong, 528251, China

RECRUITING

Foshan Nanhai District People's Hospital

Foshan, Guangdong, China

RECRUITING

Foshan No.1 people's hospital

Foshan, Guangdong, China

RECRUITING

Foshan Sanshui People's Hospital

Foshan, Guangdong, China

RECRUITING

Foshan Second People's Hospital

Foshan, Guangdong, China

RECRUITING

Guangdong Provincial Hospital of Integrative Medicine

Foshan, Guangdong, China

RECRUITING

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 225200, China

RECRUITING

The First Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510235, China

RECRUITING

Guangzhou Redcross Hospital

Guangzhou, Guangdong, 510240, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch (Guangzhou Charity Hospital)

Guangzhou, Guangdong, 510370, China

NOT YET RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

RECRUITING

The Fifth Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510900, China

NOT YET RECRUITING

Guangdong Agricultural Reclamation Central Hospital

Guangzhou, Guangdong, China

RECRUITING

Guangdong Cliffod Hospital

Guangzhou, Guangdong, China

RECRUITING

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Hua Du District People's Hospital of Guangzhou

Guangzhou, Guangdong, China

RECRUITING

Panyu District people's hospital of Guangzhou

Guangzhou, Guangdong, China

RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

The Sixth Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guanzhou, Guangdong, China

RECRUITING

Heyuan People's Hospital

Heyuan, Guangdong, China

RECRUITING

Huizhou First People Hospital

Huizhou, Guangdong, 516001, China

RECRUITING

Huizhou Central People's Hospital

Huizhou, Guangdong, China

RECRUITING

The People's Hospital of Jiangmen

Jiangmen, Guangdong, 529000, China

RECRUITING

Jiangmen Center hospital

Jiangmen, Guangdong, China

RECRUITING

Jieyang People's Hospital

Jieyang, Guangdong, China

RECRUITING

Kaiping Center Hospital

Kaiping, Guangdong, China

RECRUITING

Lianjiang People's Hospital

Lianjiang, Guangdong, China

RECRUITING

Lianping County People's Hospital

Lianping, Guangdong, 517100, China

NOT YET RECRUITING

The Fourth Affiliated Hospital of Guangzhou Medical University

Licheng, Guangdong, China

RECRUITING

Maoming Hospital of Traditional Chinese Medicine

Maoming, Guangdong, China

RECRUITING

Maoming People's Hospital

Maoming, Guangdong, China

RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, 514011, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital

Meizhou, Guangdong, 514799, China

RECRUITING

Puning People's Hospital

Puning, Guangdong, China

RECRUITING

Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

RECRUITING

Fogang People Hospital

Qingyuan, Guangdong, 511600, China

RECRUITING

Qingyuan Hospital of Traditional Chinese Medicine

Qingyuan, Guangdong, China

RECRUITING

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515031, China

WITHDRAWN

The first Affiliated Hospital of Shantou Medical University

Shantou, Guangdong, 515041, China

RECRUITING

Shantou Chaonan Minsheng Hospital

Shantou, Guangdong, 515144, China

RECRUITING

Shanwei People's Hospital

Shanwei, Guangdong, China

RECRUITING

Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University

Shanwei, Guangdong, China

RECRUITING

Wengyuan People Hospital

Shaoguan, Guangdong, 512600, China

RECRUITING

Shaoguan First People's Hospital

Shaoguan, Guangdong, China

RECRUITING

The First People's Hospital of Shaoguan

Shaoguan, Guangdong, China

RECRUITING

Yuebei People's Hospital

Shaoguan, Guangdong, China

RECRUITING

The Seventh Affiliated Hospital of Sun Yat-sen

Shenzhen, Guangdong, 510275, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

Shenzhen Baoan People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China

RECRUITING

Shenzhen Longhua District People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Shenzhen No.2 people's hospital

Shenzhen, Guangdong, China

RECRUITING

The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)

Shenzhen, Guangdong, China

RECRUITING

ShunDe Hospital Guangzhou University of Chinese Medicine

Shunde, Guangdong, China

RECRUITING

The Eighth Affiliated Hospital of Southern Medical University, The First People's Hospital of Shunde

Shunde, Guangdong, China

RECRUITING

Nanxiong People Hospital

Xiongzhou, Guangdong, 512499, China

RECRUITING

People's Hospital of Yangdong District Yangjiang City

Yangjiang, Guangdong, 529900, China

RECRUITING

Yangjiang Hospital of Traditional Chinese Medicine

Yangjiang, Guangdong, China

RECRUITING

Yangjiang People's Hospital

Yangjiang, Guangdong, China

RECRUITING

People Hospital of Yingde City Guangdong Province

Yingcheng, Guangdong, China

RECRUITING

Yunfu People's Hospital

Yunfu, Guangdong, China

RECRUITING

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524000, China

RECRUITING

Central People's Hospital of Zhanjiang

Zhanjiang, Guangdong, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University Zhaoqing Hospital

Zhaoqing, Guangdong, 526070, China

NOT YET RECRUITING

Zhaoqing first people's hospital

Zhaoqing, Guangdong, China

RECRUITING

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

RECRUITING

Zhongshan Traditional Chinese Hospital

Zhongshan, Guangdong, China

WITHDRAWN

Zhongshan Xiaolan People's Hospital

Zhongshan, Guangdong, China

RECRUITING

Jinwan Center Hospital of Zhuhai

Zhuhai, Guangdong, China

RECRUITING

The fifth affiliated hospital of sun yat-sen university

Zhuhai, Guangdong, China

RECRUITING

Zhuhai People's Hospital

Zhuhai, Guangdong, China

RECRUITING

Shantou Central Hospital

Shantou, Guanggong, 515100, China

RECRUITING

The Affiliated Hospital of Youjiang Ethnic Medicine College

Baise City, Guangxi, China

RECRUITING

The first affiliated hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Anshun Xixiu District People's Hispital

Anshun, Guizhou, 561000, China

NOT YET RECRUITING

China Guihang 302 Hospital

Anshun, Guizhou, 561000, China

RECRUITING

Anshun People Hospital

Anshun, Guizhou, 561099, China

RECRUITING

Guizhou Province Peple's Hospital

Guiyang, Guizhou, China

WITHDRAWN

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570105, China

NOT YET RECRUITING

Hainan Provincial People's Hospital

Haikou, Hainan, China

RECRUITING

Xinyang Central Hospital

Xinyang, Henan, China

RECRUITING

Huangshi Central Hospital

Huangshi, Hubei, 435000, China

NOT YET RECRUITING

Jingmen Central Hospital

Jingmen, Hubei, 448001, China

NOT YET RECRUITING

Jingzhou Central Hospital

Jingzhou, Hubei, 434020, China

NOT YET RECRUITING

Wuhan Puren Hospital

Wuhan, Hubei, 430012, China

NOT YET RECRUITING

The First People's Hospital of Jiangxia District, Wuhan City

Wuhan, Hubei, 430200, China

NOT YET RECRUITING

The Central Hospital of Wuhan

Wuhan, Hubei, China

RECRUITING

The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University

Wuhan, Hubei, China

RECRUITING

Wuhan No.1 People's Hospital

Wuhan, Hubei, China

RECRUITING

Yichang central people's hospital

Wuhan, Hubei, China

WITHDRAWN

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

WITHDRAWN

Xiangyang Central Hospital

Xiangyang, Hubei, 441021, China

RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

RECRUITING

The third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

WITHDRAWN

Nantong Haimen People's Hospital

Nantong, Jiangsu, 226199, China

RECRUITING

Xuzhou Mining Group General Hospital

Xuzhou, Jiangsu, 221006, China

NOT YET RECRUITING

Subei People's Hospital

Yangzhou, Jiangsu, 225001, China

RECRUITING

Ganzhou Municiple Hospital

Ganzhou, Jiangxi, 341000, China

RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

RECRUITING

Jiujiang No.1people's Hospital

Jiujiang, Jiangxi, China

RECRUITING

Jiangxi Province Peple's Hospital

Nanchang, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

WITHDRAWN

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

Xi’an, Shanxi, 710004, China

RECRUITING

The First Affiliated Hospital of Air Force Military Medical University

Xi’an, Shanxi, China

WITHDRAWN

Sichuan Province People's Hospital

Chengdu, Sichuan, China

RECRUITING

Jiashi County People's Hospital

Kashgar, Xinjiang, 844399, China

RECRUITING

Shache County People's Hospital

Kashgar, Xinjiang, 844700, China

RECRUITING

The First People's Hospital of Kashi Prefecture

Kashgar, Xinjiang, China

RECRUITING

The Second People's Hospital of Kashi Prefecture

Kashgar, Xinjiang, China

RECRUITING

The First Affiliated Hospital of Shihezi University Medical College

Shihezi, Xinjiang, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

WITHDRAWN

The People's hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

WITHDRAWN

Fengqing People's Hospital of Yunnan Province

Lincang, Yunnan, China

RECRUITING

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Lishui City Center Hospital

Lishui, Zhejiang, 323020, China

NOT YET RECRUITING

Zhoushan Hospital

Zhoushan, Zhejiang, 316100, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Xueqing Yu

    Guangdong Provincial People's Hospital

    STUDY CHAIR
  • Vlado Perkovic

    The University of New South Wales Sydney

    STUDY CHAIR
  • Muh Geot Wong

    The George Institute

    STUDY DIRECTOR
  • Wei Chen

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR
  • Li Fan

    Guangdong Provincial People's Hospital

    STUDY DIRECTOR
  • Zhiming Ye

    Guangdong Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic designs
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

May 8, 2020

Study Start

July 30, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Locations