Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

Efficacy of Monitoring of Aspirin Responsiveness in the Prevention of Cardiovascular Events and Decrease in Bleeding Complications in Patients With End-Stage Kidney Disease Undergoing Hemodialysis

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01198379

Enrollment

Registered

2010-09-10

Start date

2010-02-28

Completion date

2018-01-15

Last updated

2019-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease

Keywords

aspirin, aspirin resistance, hemodialysis, cardiovascular, Prevalence of aspirin resistance, cardiovascular events, and safety profile

Brief summary

The study is prospectively initiated to: (1) evaluate the alterations in platelet function to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant and aspirin-sensitive patients.

Interventions

DRUGaspirin

aspirin 100 mg qd for 3 years

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* patients with end-stage renal disease who are undergoing long-term hemodialysis.

Exclusion criteria

Patients will be excluded if there is evidence of * a recent history of acute uremia, * previous adverse reaction to a aspirin or history of aspirin hypersensitivity (eg, aspirin-induced asthma or angioedema), * concurrent treatment with other antiplatelet agent (clopidogrel or ticlopidine), steroidal drugs, or nonsteroidal anti-inflammatory drugs, * high immediate risk for bleeding (eg, active peptic ulceration, recent injury, or hemophilia), or * life-threatening condition other than end-stage renal disease or vascular disease (eg, non-skin cancer).

Design outcomes

Primary

Measure	Time frame
the prevalence of aspirin resistance	3 years

Secondary

Measure	Time frame
the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure)	3 years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026