Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hemodialysis patients who are taking plavix daily

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patient on hemodialysis taking plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day ( one study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day (one study visit)

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Staten Island University Hospital
• Investigators: Principal Investigator: Suzanne El-Sayegh, MD, Staten Island University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Plavix or clopidogrel resistance
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 10-016