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

Information source: University of Patras
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemodialysis; Chronic Renal Failure

Intervention: Prasugrel (Drug); Clopidogrel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Patras

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.

Clinical Details

Official title: 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

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

Primary outcome: Platelet Reactivity Units (PRU)assessed by VerifyNow P2Y12(Accumetrics)

Secondary outcome:

Major Adverse Cardiac Events (death, myocardial infarction, revascularization)

Hemorrhage

Stroke

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age ≥18 years old 2. History of chronic renal failure under hemodialysis for at least 6 months 3. Under clopidogrel 75mg/day treatment for at least 7 days before randomization 4. Informed consent obtained in writing Exclusion Criteria: 1. Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit. 2. Pregnancy 3. Breastfeeding 4. Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up. 5. Malignancy 6. Acute coronary syndrome or hemodynamic instability within 30 days prior to randomization 7. Requirement for oral anticoagulant prior to the Day 30 visit 8. Requirement for discontinuation of thienopyridine treatment prior to the Day 30 visit 9. Treatment with IIb/IIIa inhibitors within 30 days prior to randomization or planned administration prior to the Day 30 visit 10. Known hypersensitivity to prasugrel or clopidogrel. 11. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months. 12. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy. 13. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm). 14. Thrombocytopenia (<100. 000 / μL) at randomization 15. Known liver failure (bilirubin > 2mg/dl)

Locations and Contacts

Patras University Hospital, Patras, Achaia 26500, Greece
Additional Information

Starting date: May 2010
Last updated: November 15, 2010

Page last updated: August 20, 2015

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