Clinical trial

ASPIrin in Reducing Events in Dialysis

Name
GDPH-CH-2774
Description
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.
Trial arms
Trial start
2020-07-30
Estimated PCD
2026-09-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Aspirin 100 mg Oral Tablet
Aspirin 100 mg tablet daily
Arms:
Aspirin
Matching Placebo
Matching Placebo 1 pill daily
Arms:
Matching Placebo
Size
9000
Primary endpoint
Number of Participants with composite of major cardiovascular events (3-point MACE)
From trial initiation to any event first occurrence, up to 5 years.
Eligibility criteria
Inclusion Criteria: * Incident or prevalent adults (≥18 years old) dialysis patients are included in the Dialysis Registry. * An 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic designs', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 9000, 'type': 'ESTIMATED'}}
Updated at
2024-03-29

1 organization

2 products

1 indication

Product
Aspirin