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Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01198379
Recruitment Status : Unknown
Verified February 2010 by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : September 27, 2010
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by:
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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Drug: aspirin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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 Start Date : February 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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



Primary Outcome Measures :
  1. the prevalence of aspirin resistance [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198379


Contacts
Contact: Ying-Hwa Chen, MD, PhD yhchen@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Ying-Hwa Chen, MD, PhD       yhchen@vghtpe.gov.tw   
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei Veterans General Hospital, Taiwan
Investigators
Study Director: Der-Cherng Tarng, MD, PhD Taipei Veterans General Hospital, Taiwan

Responsible Party: Ying-Hwa Chen, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01198379     History of Changes
Other Study ID Numbers: BTCGHTN01
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: February 2010

Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
aspirin
aspirin resistance
hemodialysis
cardiovascular
Prevalence of aspirin resistance, cardiovascular events, and safety profile

Additional relevant MeSH terms:
Aspirin
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics