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

Launched by UNIVERSITY OF PATRAS · Jul 1, 2010

Keywords

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Gender

ALL

Eligibility 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)