Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

Chronic Kidney Disease Clinical Trial

Official title:

Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364779
• Other study ID #: 10-025
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: May 14, 2013
• Start date: April 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	staten island University Hospital nephrology clinic	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of aspirin resistance in chronic kidney disease patients	Blood drawn for the Accumetric test	2 years	No
Secondary	risk factors contributing to aspirin resistance in this population.	risk factors	2 years	No