Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

Cardiovascular Disease Clinical Trial

Official title:

Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865890
• Other study ID #: 10-016
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: May 30, 2013
• Start date: June 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No