Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
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.