Cardiovascular DiseaseNCT01865890
Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients
An observational study of Cardiovascular Disease, run by Northwell Health at 1 site in United States.
Trial summary
The investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2011
- 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: Hemodialysis patients who are taking plavix daily
Who may be able to join
- All patients on hemodialysis taking Plavix
Who cannot join
- known to have bleeding disorder
- Severely anemic with hemoglobin level (Hb) < 10g/dl
- Low Platelets < 10000
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
The investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed.
Read the detailed description
Cardiovascular disease is very frequent in hemodialysis patients. Lot of hemodialysis patients are on Clopidogrel (plavix). Their is some evidence that clopidogrel is not effective in hemodialysis as it is effective in patient without kidney problem.
VerifyNow plavix is a machine that measure the ability of the blood to clot after giving plavix.
We will collect blood from hemodialysis patients on plavix and check the ability of their blood to clot and thus indirectly measuring the efficacy of Plavix.
- Conditions
- Cardiovascular Disease
- Keywords
- Plavix or clopidogrel resistance
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient on hemodialysis taking plavix | patient on hemodialysis taking plavix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence Of Plavix resistance
Plavix resistance is reported using the PRU values given by the VerifyNow machine. PRU is P2Y12 Reaction Units which is correlated with platelet aggregation.
Measured: 1 day ( one study visit)
Secondary outcomes (1)
assess the risk factors for plavix resistance in the hemodialysis population
Coronary Artery Disease (CAD) is very common in dialysis patients. Treatment of CAD include medical therapy, stent placement and surgery. Since Plavix is a medication that is commonly used after stent placement, we would like to assess the efficacy of this medication in this patient population.
Measured: 1 day (one study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJun 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT01865890
- Sponsor's protocol ID
- 10-016
- Status last verified
- May 2013
- First submitted
- 9 Jun 2010
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01865890
- Acronym / sponsor ID
- 10-016
- Conditions
- Cardiovascular Disease
- Keywords
- Plavix or clopidogrel resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 31 May 2013 (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 investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed.
Detailed description
Cardiovascular disease is very frequent in hemodialysis patients. Lot of hemodialysis patients are on Clopidogrel (plavix). Their is some evidence that clopidogrel is not effective in hemodialysis as it is effective in patient without kidney problem.
VerifyNow plavix is a machine that measure the ability of the blood to clot after giving plavix.
We will collect blood from hemodialysis patients on plavix and check the ability of their blood to clot and thus indirectly measuring the efficacy of Plavix.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient on hemodialysis taking plavix | – | –patient on hemodialysis taking plavix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients who are taking plavix daily
Key inclusion criteria (1 listed)
- All patients on hemodialysis taking Plavix
Key exclusion criteria (3 listed)
- known to have bleeding disorder
- Severely anemic with hemoglobin level (Hb) < 10g/dl
- Low Platelets < 10000
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 Plavix resistance
Time frame: 1 day ( one study visit)
Plavix resistance is reported using the PRU values given by the VerifyNow machine. PRU is P2Y12 Reaction Units which is correlated with platelet aggregation.
1 secondary outcome
assess the risk factors for plavix resistance in the hemodialysis population
Time frame: 1 day (one study visit)
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 31 May 2013.
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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 Cardiovascular 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 3 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 31 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 Plavix resistance (time frame: 1 day ( one study visit)). 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 31 May 2013.