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Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

This study has been completed.
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01364779
First received: May 27, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes

May 27, 2011
May 14, 2013
April 2010
March 2012   (final data collection date for primary outcome measure)
prevalence of aspirin resistance in chronic kidney disease patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Blood drawn for the Accumetric test
determine the prevalence of aspirin resistance in chronic kidney disease patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Blood will de drawn for the Accumetric test to assess for aspirin resistance/sensitivity in patients who are eligible for the study visiting the nephrology clinic
Complete list of historical versions of study NCT01364779 on ClinicalTrials.gov Archive Site
risk factors contributing to aspirin resistance in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
risk factors
determine possible risk factors contributing to aspirin resistance in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
analysing data and risk factors that might be contributing to aspirin resistance
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Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients
Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

The primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. The secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.

A cross-sectional of "aspirin resistance in hemodialysis patients" previously done in our institution showed that 23/66 (34.7%) hemodialysis patients were aspirin resistant. In a recent systematic review, renal impairment was associated with aspirin resistance . This association was seen in only two out of the twenty studies used in this meta-analysis . Both these studies are from the same center with a predominant Asian population. In this study we will try to evaluate the prevalence of aspirin resistance in CKD patient without being limited to a specific ethnicity.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Blood draw
Probability Sample

Patients presenting to the nephrology clinic at SIUH and the nephrology clinic at Staten Island rehab and the admitted patients who give consent.
Chronic Kidney Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with known structural kidney disease as evident by history or by urinalysis and CKD stage III or IV determined by MDRD formula and who are taking aspirin.

Exclusion Criteria:

  • Younger than 18 years of age.
  • Bleeding disorder or myeloproliferative disorders.
  • Thrombocytopenia with platelets < 100.000.
  • Malignancy.
  • Acute hemorrhagic disease.
  • A recent history of receipt of platelet glycoprotein IIb/IIIa blockers.
  • Liver disease as evident by abnormal liver function and total bilirubin > 2mg/dl.
  • use of anticoagulation.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01364779
10-025
Yes
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Staten Island University Hospital
Principal Investigator: Suzanne El_Sayegh, MD Staten Island University Hospital
North Shore Long Island Jewish Health System
May 2013

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