ASPIrin in Reducing Events in Dialysis ( ASPIRED )

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ASPIrin in Reducing Events in Dialysis

Conditions
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CKD (Chronic Kidney Disease) Stage 5D

Intervention / Treatment
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* Drug: Aspirin 100 mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who are entered into the Chinese PD and HD dialysis registry Expected requirement for ongoing maintenance dialysis Willing and able to provide informed consent Exclusion Criteria: Requirement of antiplatelet agent or oral anticoagulation, in the view of the treating physician Contraindication to aspirin Dialysis requirement due to acute kidney injure I with the expectation of kidney function recovery History of haemorrhagic stroke or intracranial bleed within the past 12 months Coagulopathy from any cause

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic designs
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Aspirin tablet 100mg daily | Drug: Aspirin 100 mg Oral Tablet<br>* Aspirin 100 mg tablets daily<br>|
| Placebo Comparator: Matching Placebo<br>Placebo tablet 1 pill daily | Drug: Aspirin 100 mg Oral Tablet<br>* Aspirin 100 mg tablets daily<br>|

What is the study measuring?
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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 composite of the primary outcome plus all-cause death | A composite of cardiovascular death, myocardial infarction, ischemic stroke or 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. | 
| Myocardial infarction |  | From trial initiation to any event first occurrence, up to 5 years. | 
| Number of Participants with stroke |  | From trial initiation to any event first occurrence, up to 5 years. | 
| 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 haemorrhagic stroke |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin, Dialysis, End Stage Kidney Disease