Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01364779
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : May 15, 2013
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Suzanne El-Sayegh, Northwell Health

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Chronic Kidney Disease

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients
Study Start Date : April 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Aspirin

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. prevalence of aspirin resistance in chronic kidney disease patients [ Time Frame: 2 years ]
    Blood drawn for the Accumetric test


Secondary Outcome Measures :
  1. risk factors contributing to aspirin resistance in this population. [ Time Frame: 2 years ]
    risk factors


Biospecimen Retention:   Samples Without DNA
Blood draw

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the nephrology clinic at SIUH and the nephrology clinic at Staten Island rehab and the admitted patients who give consent.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01364779


Locations
Layout table for location information
United States, New York
staten island University Hospital nephrology clinic
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Staten Island University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Suzanne El_Sayegh, MD Staten Island University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, Northwell Health
ClinicalTrials.gov Identifier: NCT01364779    
Other Study ID Numbers: 10-025
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Keywords provided by Suzanne El-Sayegh, Northwell Health:
aspirin
Chronic kidney disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes