Back to resultsAspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients
Primary Purpose
End-Stage Renal Disease
Status
Withdrawn
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
aspirin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease focused on measuring aspirin, aspirin resistance, hemodialysis, cardiovascular, Prevalence of aspirin resistance, cardiovascular events, and safety profile
Eligibility Criteria
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).
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aspirin
Sugar pills
Arm Description
Hemodialysis (HD) patients receive placebo not containing aspirin in this study.
Outcomes
Primary Outcome Measures
the prevalence of aspirin resistance
Secondary Outcome Measures
the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure)
Full Information
NCT ID
NCT01198379
First Posted
August 24, 2010
Last Updated
January 15, 2019
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01198379
Brief Title
Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
February 2010 (Anticipated)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborators
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
aspirin, aspirin resistance, hemodialysis, cardiovascular, Prevalence of aspirin resistance, cardiovascular events, and safety profile
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Title
Sugar pills
Arm Type
Placebo Comparator
Arm Description
Hemodialysis (HD) patients receive placebo not containing aspirin in this study.
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
aspirin 100 mg qd for 3 years
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
the prevalence of aspirin resistance
Time Frame
3 years
Secondary Outcome Measure Information:
Title
the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Der-Cherng Tarng, MD, PhD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35224730
Citation
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Results Reference
derived
Learn more about this trial
Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients
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