Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01865890

Enrollment

100

Registered

2013-05-31

Start date

2010-06-30

Completion date

2011-04-30

Last updated

2013-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Plavix or clopidogrel resistance

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence Of Plavix resistance	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

Measure	Time frame	Description
assess the risk factors for plavix resistance in the hemodialysis population	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.

Countries

United States

Outcome results