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

75
On Track

Trial Health Score

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

Enrollment
9,082

participants targeted

Target at P75+ for phase_4

Timeline
3mo left

Started Jul 2020

Longer than P75 for phase_4

Geographic Reach
1 country

127 active sites

Status
active not 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 Progress96%
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
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

6.2 years

First QC Date

April 23, 2020

Last Update Submit

September 10, 2026

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 (127)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Shanghang County Hospital

Longyan, Fujian, 364299, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Dongguan Donghua Hospital

Dongguan, Guangdong, 523413, China

Location

Dongguan Hospital of Integrative Traditional Chinese and Western Medicine

Dongguan, Guangdong, 523819, China

Location

Dongguan Houjie Hospital

Dongguan, Guangdong, 523955, China

Location

Dongguan Eighth People's Hospital

Dongguan, Guangdong, China

Location

Dongguan Marina Bay Center Hospital

Dongguan, Guangdong, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

Foshan Gaoming District People's Hospital

Foshan, Guangdong, 528000, China

Location

The Second People Hospital of Foshan Nanhai

Foshan, Guangdong, 528251, China

Location

Foshan Nanhai District People's Hospital

Foshan, Guangdong, China

Location

Foshan No.1 people's hospital

Foshan, Guangdong, China

Location

Foshan Sanshui People's Hospital

Foshan, Guangdong, China

Location

Foshan Second People's Hospital

Foshan, Guangdong, China

Location

Guangdong Provincial Hospital of Integrative Medicine

Foshan, Guangdong, China

Location

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 225200, China

Location

The First Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, 510120, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510235, China

Location

Guangzhou Redcross Hospital

Guangzhou, Guangdong, 510240, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

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

Guangzhou, Guangdong, 510370, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

The Fifth Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510900, China

Location

Guangdong Agricultural Reclamation Central Hospital

Guangzhou, Guangdong, China

Location

Guangdong Cliffod Hospital

Guangzhou, Guangdong, China

Location

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Location

Hua Du District People's Hospital of Guangzhou

Guangzhou, Guangdong, China

Location

Panyu District people's hospital of Guangzhou

Guangzhou, Guangdong, China

Location

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Location

The Sixth Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guanzhou, Guangdong, China

Location

Heyuan People's Hospital

Heyuan, Guangdong, China

Location

Huizhou First People Hospital

Huizhou, Guangdong, 516001, China

Location

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Location

The People's Hospital of Jiangmen

Jiangmen, Guangdong, 529000, China

Location

Jiangmen Center hospital

Jiangmen, Guangdong, China

Location

Jieyang People's Hospital

Jieyang, Guangdong, China

Location

Kaiping Center Hospital

Kaiping, Guangdong, China

Location

Lianjiang People's Hospital

Lianjiang, Guangdong, China

Location

Lianping County People's Hospital

Lianping, Guangdong, 517100, China

Location

The Fourth Affiliated Hospital of Guangzhou Medical University

Licheng, Guangdong, China

Location

Maoming Hospital of Traditional Chinese Medicine

Maoming, Guangdong, China

Location

Maoming People's Hospital

Maoming, Guangdong, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, 514011, China

Location

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

Meizhou, Guangdong, 514799, China

Location

Puning People's Hospital

Puning, Guangdong, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

Location

Fogang People Hospital

Qingyuan, Guangdong, 511600, China

Location

Qingyuan Hospital of Traditional Chinese Medicine

Qingyuan, Guangdong, China

Location

The first Affiliated Hospital of Shantou Medical University

Shantou, Guangdong, 515041, China

Location

Shantou Chaonan Minsheng Hospital

Shantou, Guangdong, 515144, China

Location

Shanwei People's Hospital

Shanwei, Guangdong, China

Location

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

Shanwei, Guangdong, China

Location

Wengyuan People Hospital

Shaoguan, Guangdong, 512600, China

Location

Shaoguan First People's Hospital

Shaoguan, Guangdong, China

Location

The First People's Hospital of Shaoguan

Shaoguan, Guangdong, China

Location

Yuebei People's Hospital

Shaoguan, Guangdong, China

Location

The Seventh Affiliated Hospital of Sun Yat-sen

Shenzhen, Guangdong, 510275, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

Shenzhen Baoan People's Hospital

Shenzhen, Guangdong, China

Location

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China

Location

Shenzhen Longhua District People's Hospital

Shenzhen, Guangdong, China

Location

Shenzhen No.2 people's hospital

Shenzhen, Guangdong, China

Location

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

Shenzhen, Guangdong, China

Location

ShunDe Hospital Guangzhou University of Chinese Medicine

Shunde, Guangdong, China

Location

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

Shunde, Guangdong, China

Location

Nanxiong People Hospital

Xiongzhou, Guangdong, 512499, China

Location

People's Hospital of Yangdong District Yangjiang City

Yangjiang, Guangdong, 529900, China

Location

Yangjiang Hospital of Traditional Chinese Medicine

Yangjiang, Guangdong, China

Location

Yangjiang People's Hospital

Yangjiang, Guangdong, China

Location

People Hospital of Yingde City Guangdong Province

Yingcheng, Guangdong, China

Location

Yunfu People's Hospital

Yunfu, Guangdong, China

Location

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524000, China

Location

Central People's Hospital of Zhanjiang

Zhanjiang, Guangdong, China

Location

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

Zhaoqing, Guangdong, 526070, China

Location

Zhaoqing first people's hospital

Zhaoqing, Guangdong, China

Location

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Location

Zhongshan Xiaolan People's Hospital

Zhongshan, Guangdong, China

Location

Jinwan Center Hospital of Zhuhai

Zhuhai, Guangdong, China

Location

The fifth affiliated hospital of sun yat-sen university

Zhuhai, Guangdong, China

Location

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Location

Shantou Central Hospital

Shantou, Guanggong, 515100, China

Location

The Affiliated Hospital of Youjiang Ethnic Medicine College

Baise City, Guangxi, China

Location

The first affiliated hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Anshun Xixiu District People's Hispital

Anshun, Guizhou, 561000, China

Location

China Guihang 302 Hospital

Anshun, Guizhou, 561000, China

Location

Anshun People Hospital

Anshun, Guizhou, 561099, China

Location

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570105, China

Location

Hainan Provincial People's Hospital

Haikou, Hainan, China

Location

Xinyang Central Hospital

Xinyang, Henan, China

Location

Huangshi Central Hospital

Huangshi, Hubei, 435000, China

Location

Jingmen Central Hospital

Jingmen, Hubei, 448001, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, 434020, China

Location

Wuhan Puren Hospital

Wuhan, Hubei, 430012, China

Location

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

Wuhan, Hubei, 430200, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, China

Location

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

Wuhan, Hubei, China

Location

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

Wuhan, Hubei, China

Location

Wuhan No.1 People's Hospital

Wuhan, Hubei, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441021, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

The third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Nantong Haimen People's Hospital

Nantong, Jiangsu, 226199, China

Location

Xuzhou Mining Group General Hospital

Xuzhou, Jiangsu, 221006, China

Location

Subei People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Ganzhou Municiple Hospital

Ganzhou, Jiangxi, 341000, China

Location

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Location

Jiujiang No.1people's Hospital

Jiujiang, Jiangxi, China

Location

Jiangxi Province Peple's Hospital

Nanchang, Jiangxi, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

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

Xi’an, Shanxi, 710004, China

Location

Sichuan Province People's Hospital

Chengdu, Sichuan, China

Location

Jiashi County People's Hospital

Kashgar, Xinjiang, 844399, China

Location

Shache County People's Hospital

Kashgar, Xinjiang, 844700, China

Location

The First People's Hospital of Kashi Prefecture

Kashgar, Xinjiang, China

Location

The Second People's Hospital of Kashi Prefecture

Kashgar, Xinjiang, China

Location

The First Affiliated Hospital of Shihezi University Medical College

Shihezi, Xinjiang, China

Location

Fengqing People's Hospital of Yunnan Province

Lincang, Yunnan, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

Lishui City Center Hospital

Lishui, Zhejiang, 323020, China

Location

Zhoushan Hospital

Zhoushan, Zhejiang, 316100, China

Location

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

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

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 14, 2026

Record last verified: 2026-09

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