Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by:
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier:
NCT01198379
First received: August 24, 2010
Last updated: September 23, 2010
Last verified: February 2010

August 24, 2010
September 23, 2010
February 2010
February 2011   (final data collection date for primary outcome measure)
the prevalence of aspirin resistance [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01198379 on ClinicalTrials.gov Archive Site
the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
End-Stage Renal Disease
  • Drug: aspirin
    aspirin 100 mg qd for 3 years
  • Drug: Placebo
  • Experimental: Aspirin
    Intervention: Drug: aspirin
  • Placebo Comparator: Sugar pills
    Hemodialysis (HD) patients receive placebo not containing aspirin in this study.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
February 2013
February 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact: Ying-Hwa Chen, MD, PhD yhchen@vghtpe.gov.tw
Taiwan
 
NCT01198379
BTCGHTN01
Yes
Ying-Hwa Chen, Taipei Veterans General Hospital
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei Veterans General Hospital, Taiwan
Study Director: Der-Cherng Tarng, MD, PhD Taipei Veterans General Hospital, Taiwan
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP