ASPIrin in Reducing Events in Dialysis ( ASPIRED )
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin 100 mg Oral Tablet
DrugAspirin 100 mg tablet daily
Matching Placebo
DrugMatching Placebo 1 pill daily
Treatment groups
9,000 Participants
are divided into 2 treatment groupsGroup A: AspirinActive comparator 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
Number of Participants with Myocardial infarction
Time frame
From trial initiation to any event first occurrence, up to 5 years.Other outcomes
1
Major bleeding
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.
Time frame
From trial initiation to any event first occurrence, up to 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangdong Provincial People's Hospital
Lead sponsor
The George Institute
Collaborator
Source ClinicalTrials.gov