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
  Purpose

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
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • prevalence of aspirin resistance in chronic kidney disease patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Blood drawn for the Accumetric test


Secondary Outcome Measures:
  • risk factors contributing to aspirin resistance in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    risk factors


Biospecimen Retention:   Samples Without DNA

Blood draw


Enrollment: 15
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364779

Locations
United States, New York
staten island University Hospital nephrology clinic
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Staten Island University Hospital
Investigators
Principal Investigator: Suzanne El_Sayegh, MD Staten Island University Hospital
  More Information

No publications provided

Responsible Party: Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01364779     History of Changes
Other Study ID Numbers: 10-025
Study First Received: May 27, 2011
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
aspirin
Chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014