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Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

2014-08-27 03:12:29 | BioPortfolio

Summary

Clopidogrel administration is essential in patients undergoing percutaneous coronary intervention, in patients with previous stroke, in patients under chronic hemodialysis via fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a viable option. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Additionally, hemodialysis via the dialysis filter causes a decrease in glycoprotein platelet receptors, potentially associated with thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel 150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be carried out, without an interventing washout period. All patients will undergo platelet reactivity assessment, documentation of major adverse cardiac events and documentation of any serious adverse events(stroke, bleeding)at day 15 and day 30.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hemodialysis

Intervention

Prasugrel, Clopidogrel

Location

Patras University Hospital
Patras
Achaia
Greece
26500

Status

Recruiting

Source

University of Patras

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:29-0400

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Medical and Biotech [MESH] Definitions

Hospital units in which care is provided the hemodialysis patient. This includes hemodialysis centers in hospitals.

Long-term maintenance hemodialysis in the home.

The combination of hemodialysis and hemofiltration either simultaneously or sequentially. Convective transport (hemofiltration) may be better for removal of larger molecular weight substances and diffusive transport (hemodialysis) for smaller molecular weight solutes.

Solutions prepared for hemodialysis. The composition of the pre-dialysis solution may be varied in order to determine the effect of solvated metabolites on anoxia, malnutrition, acid-base balance, etc. Of principal interest are the effect of the choice of buffers (e.g., acetate or carbonate), the addition of cations (Na+, K+, Ca2+), and addition of carbohydrates (glucose).

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