Status:
COMPLETED
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Lead Sponsor:
University of Patras
Conditions:
Hemodialysis
Chronic Renal Failure
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- History of chronic renal failure under hemodialysis for at least 6 months
- Under clopidogrel 75mg/day treatment for at least 7 days before randomization
- Informed consent obtained in writing
Exclusion
- 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.
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
- Malignancy
- Acute coronary syndrome or hemodynamic instability within 30 days prior to randomization
- Requirement for oral anticoagulant prior to the Day 30 visit
- Requirement for discontinuation of thienopyridine treatment prior to the Day 30 visit
- Treatment with IIb/IIIa inhibitors within 30 days prior to randomization or planned administration prior to the Day 30 visit
- Known hypersensitivity to prasugrel or clopidogrel.
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.
- Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thrombocytopenia (\<100.000 / μL) at randomization
- Known liver failure (bilirubin \> 2mg/dl)
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01155765
Start Date
May 1 2010
End Date
July 1 2010
Last Update
November 16 2010
Active Locations (1)
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1
Patras University Hospital
Pátrai, Achaia, Greece, 26500