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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10305
      • staten island University Hospital nephrology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of aspirin resistance in chronic kidney disease patients	Blood drawn for the Accumetric test	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factors contributing to aspirin resistance in this population.	risk factors	2 years

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Staten Island University Hospital
• Investigators: Principal Investigator: Suzanne El_Sayegh, MD, Staten Island University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 14, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Chronic kidney disease; aspirin
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 10-025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No