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
Qualifiers
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
Treatments tested in this trial
- Aspirin 100 mg Oral Tablet
- Matching Placebo
Treatment groups
9,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Guangdong Provincial People's Hospital
Lead sponsor
The George Institute
Collaborator
Source ClinicalTrials.gov