Chronic Kidney DiseaseNCT01364779
Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients
An observational study of Chronic Kidney Disease, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
staten island University Hospital nephrology clinic
Staten Island, New York, 10305
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- aspirin, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of aspirin resistance in chronic kidney disease patients
Blood drawn for the Accumetric test
Measured: 2 years
Secondary outcomes (1)
risk factors contributing to aspirin resistance in this population.
risk factors
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Suzanne El-Sayegh, Northwell Health
- Investigators
- Suzanne El_Sayegh, MD, Principal investigator, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364779
- Sponsor's protocol ID
- 10-025
- Status last verified
- May 2013
- First submitted
- 27 May 2011
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT01364779
- Acronym / sponsor ID
- 10-025
- Conditions
- Chronic Kidney Disease
- Keywords
- aspirin, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Younger than 18 years of age.
- Bleeding disorder or myeloproliferative disorders.
- Thrombocytopenia with platelets < 100.000.
- Malignancy.
- Acute hemorrhagic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of aspirin resistance in chronic kidney disease patients
Time frame: 2 years
Blood drawn for the Accumetric test
1 secondary outcome
risk factors contributing to aspirin resistance in this population.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne El_Sayegh, MD principal investigator
Staten Island University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of aspirin resistance in chronic kidney disease patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.