ASPIrin in Reducing Events in Dialysis ( ASPIRED )
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aspirin 100 mg Oral Tablet, Matching Placebo.
- Who it may be relevant to
- Registry conditions: CKD (Chronic Kidney Disease) Stage 5D. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ASPIrin in Reducing Events in Dialysis
Overview
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
- Drug Aspirin 100 mg Oral Tablet
Aspirin 100 mg tablet daily - Drug Matching Placebo
Matching Placebo 1 pill daily
Primary outcome measures
- 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.]
Secondary outcome measures (11)
- 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.]
- 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.]
- Number of Participants with cardiovascular death [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 [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 [Time frame: From trial initiation to any event occurrence, up to 5 years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 139 centers
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
- Shanghang County Hospital — Longyan
- The First Hospital of Lanzhou University — Lanzhou
- Dongguan Donghua Hospital — Dongguan
- Dongguan Hospital of Integrative Traditional Chinese and Western Medicine — Dongguan
- Dongguan Houjie Hospital — Dongguan
- Dongguan Eighth People's Hospital — Dongguan
- Dongguan Marina Bay Center Hospital — Dongguan
- … and 131 more centers
Identifiers
NCT: NCT04381143 · GDPH-CH-2774