NCT01155765

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

Prasugrel in Comparison to High Clopidogrel Dose for Inhibition of Platelet Reactivity as Assessed With a Point-of-Care Platelet Function Assay in Patients Undergoing Chronic Hemodialysis Presenting Resistance to the Usual Clopidogrel Dose

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis
• Chronic Renal Failure

Interventions

Type	Name	Description
DRUG	Prasugrel	Prasugrel 10 mg/day for 15 days
DRUG	Clopidogrel	Clopidogrel 150 mg/day for 15 days

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-07-02
• Last updated: 2010-11-16

Locations

1 site across 1 country: Greece