CKD (Chronic Kidney Disease) Stage 5D
Conditions
Keywords
Aspirin, Dialysis, End Stage Kidney Disease
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.
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.
Interventions
DRUGAspirin 100 mg Oral Tablet
Aspirin 100 mg tablet daily
DRUGMatching Placebo
Matching Placebo 1 pill daily
Sponsors
Guangdong Provincial People's Hospital
The George Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Pragmatic designs
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with composite of major cardiovascular events (3-point MACE) | From trial initiation to any event first occurrence, up to 5 years. | A composite of cardiovascular death, myocardial infarction, or ischemic stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | A composite of cardiovascular death, myocardial infarction, ischemic stroke or all-cause death. |
| 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. | A composite of cardiovascular death, myocardial infarction, ischemic stroke, hospitalised unstable angina (UA) or hospitalised transient ischaemic attack (TIA) |
| Number of Participants with cardiovascular death | From trial initiation to any event first occurrence, up to 5 years. | Death due to CV cause. |
| 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 all-cause death | From trial initiation to any event first occurrence, up to 5 years. | Death for any reason. |
| 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 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. | — |
| Number of Participants with ischemic events | 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). |
Countries
China
Contacts
STUDY_CHAIRXueqing Yu
Guangdong Provincial People's Hospital
STUDY_CHAIRVlado Perkovic
The University of New South Wales Sydney
STUDY_DIRECTORMuh Geot Wong
The George Institute
STUDY_DIRECTORWei Chen
First Affiliated Hospital, Sun Yat-Sen University
STUDY_DIRECTORLi Fan
Guangdong Provincial People's Hospital
STUDY_DIRECTORZhiming Ye
Guangdong Provincial People's Hospital
Outcome results
None listed