NCT01364779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

May 27, 2011

Last Update Submit

May 14, 2013

Conditions

Chronic Kidney Disease

Keywords

aspirinChronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • prevalence of aspirin resistance in chronic kidney disease patients

    Blood drawn for the Accumetric test

    2 years

Secondary Outcomes (1)

  • risk factors contributing to aspirin resistance in this population.

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

staten island University Hospital nephrology clinic

Staten Island, New York, 10305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draw

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne El_Sayegh, MD

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrology Attending, Assoc. Chair of Medicine

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 2, 2011

Study Start

April 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

US(1)