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NCT Number: NCT04381143

ASPIrin in Reducing Events in Dialysis ( ASPIRED )

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.

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Key information

Conditions

CKD (Chronic Kidney Disease) Stage 5D Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin 100 mg Oral Tablet

Drug

Aspirin 100 mg tablet daily

Matching Placebo

Drug

Matching Placebo 1 pill daily

Primary outcomes

  1. Number of Participants with composite of major cardiovascular events (3-point MACE)

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

    A composite of cardiovascular death, myocardial infarction, or ischemic stroke.

Secondary outcomes

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

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

    A composite of cardiovascular death, myocardial infarction, ischemic stroke or all-cause death.

  2. Number of Participants with composite of major cardiovascular events, hospitalised unstable angina (UA) and hospitalised transient ischaemic attack (TIA)

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

    A composite of cardiovascular death, myocardial infarction, ischemic stroke, hospitalised unstable angina (UA) or hospitalised transient ischaemic attack (TIA)

  3. Number of Participants with cardiovascular death

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

    Death due to CV cause.

  4. Number of Participants with Myocardial infarction

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

  5. Number of Participants with ischemic stroke

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

  6. Number of Participants with all-cause death

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

    Death for any reason.

  7. Number of Participants with coronary revascularization

    Time frame: From trial initiation to any event occurrence, up to 5 years.

  8. Number of Participants with fistula or graft thrombosis

    Time frame: From trial initiation to any event occurrence, up to 5 years.

  9. Number of Participants with intracranial haemorrhage

    Time frame: From trial initiation to any event occurrence, up to 5 years.

  10. Number of Participants with peripheral vascular events

    Time frame: From trial initiation to any event occurrence, up to 5 years.

  11. Number of Participants with ischemic events

    Time frame: From trial initiation to any event occurrence, up to 5 years.

    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).

Other outcomes

  1. Major bleeding

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Fan

CONTACT

[email protected]

+86-20-87755766-8174

Xueqing Yu

CONTACT

[email protected]

+86-20-83827812

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • The George Institute

Registry information

Official study title

ASPIrin in Reducing Events in Dialysis

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 8, 2020
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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