Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

Phase 4WithdrawnNCT01198379

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

End-Stage Renal Disease

Interventions

aspirinDRUG

aspirin 100 mg qd for 3 years

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

the prevalence of aspirin resistance

Time frame: 3 years

Secondary Outcomes

the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure)

Time frame: 3 years

Data from ClinicalTrials.gov

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