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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9,000
Aspirin 100 mg tablet daily
Matching Placebo 1 pill daily
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGShanghang County Hospital
Longyan, Fujian, China
RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGDongguan Donghua Hospital
Dongguan, Guangdong, China
Number of Participants with composite of major cardiovascular events (3-point MACE)
A composite of cardiovascular death, myocardial infarction, or ischemic stroke.
Time frame: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with composite of major cardiovascular events plus all-cause death
A composite of cardiovascular death, myocardial infarction, ischemic stroke or all-cause death.
Time frame: 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)
A composite of cardiovascular death, myocardial infarction, ischemic stroke, hospitalised unstable angina (UA) or hospitalised transient ischaemic attack (TIA)
Time frame: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with cardiovascular death
Death due to CV cause.
Time frame: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with Myocardial infarction
Time frame: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with ischemic stroke
Time frame: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with all-cause death
Death for any reason.
Time frame: From trial initiation to any event first occurrence, up to 5 years.
Number of Participants with coronary revascularization
Time frame: From trial initiation to any event occurrence, up to 5 years.
Number of Participants with fistula or graft thrombosis
Time frame: From trial initiation to any event occurrence, up to 5 years.
Number of Participants with intracranial haemorrhage
Time frame: From trial initiation to any event occurrence, up to 5 years.
Number of Participants with peripheral vascular events
Time frame: 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).
Time frame: From trial initiation to any event occurrence, up to 5 years.
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Dongguan Hospital of Integrative Traditional Chinese and Western Medicine
Dongguan, Guangdong, China
NOT_YET_RECRUITINGDongguan Houjie Hospital
Dongguan, Guangdong, China
NOT_YET_RECRUITINGDongguan Eighth People's Hospital
Dongguan, Guangdong, China
RECRUITINGDongguan Marina Bay Center Hospital
Dongguan, Guangdong, China
RECRUITINGDongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGDongguan Songshan Lake Center Hospital
Dongguan, Guangdong, China
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