Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

Phase 4

Withdrawn

• Conditions: End-Stage Renal Disease
• Interventions: Drug: Placebo; Drug: aspirin

• Registration Number: NCT01198379
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Status Verified: 2018-01
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pills	Placebo	Hemodialysis (HD) patients receive placebo not containing aspirin in this study.
Aspirin	aspirin	-

Primary Outcome Measures

Name	Time	Method
the prevalence of aspirin resistance	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan