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
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