Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2018-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Aspirin

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

aspirin 100 mg qd for 3 years

Sugar pills

Hemodialysis (HD) patients receive placebo not containing aspirin in this study.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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aspirin

aspirin 100 mg qd for 3 years

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No