Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

January 15, 2019 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin
Drug: aspirin
aspirin 100 mg qd for 3 years
Placebo Comparator: Sugar pills
Hemodialysis (HD) patients receive placebo not containing aspirin in this study.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the prevalence of aspirin resistance
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Director: Der-Cherng Tarng, MD, PhD, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2010

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTCGHTN01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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