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Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01865890
First Posted: May 31, 2013
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
  Purpose
The investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed.

Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Suzanne El-Sayegh, North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • assess the risk factors for plavix resistance in the hemodialysis population [ Time Frame: 1 day (one study visit) ]
    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.


Enrollment: 100
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patient on hemodialysis taking plavix
patient on hemodialysis taking plavix

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hemodialysis patients who are taking plavix daily
Criteria

Inclusion Criteria:

  • All patients on hemodialysis taking Plavix

Exclusion Criteria:

  • known to have bleeding disorder
  • Severely anemic with hemoglobin level (Hb) < 10g/dl
  • Low Platelets < 10000
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865890


Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Staten Island University Hospital
Investigators
Principal Investigator: Suzanne El-Sayegh, MD Staten Island University Hospital
  More Information

Responsible Party: Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01865890     History of Changes
Other Study ID Numbers: 10-016
First Submitted: June 9, 2010
First Posted: May 31, 2013
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by Suzanne El-Sayegh, North Shore Long Island Jewish Health System:
Plavix or clopidogrel resistance

Additional relevant MeSH terms:
Cardiovascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs