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Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01865890
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed.

Condition or disease
Cardiovascular Disease

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

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients
Study Start Date : June 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Groups and Cohorts

patient on hemodialysis taking plavix
patient on hemodialysis taking plavix

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria

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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

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

United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Staten Island University Hospital
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 Posted: May 31, 2013    Key Record Dates
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
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