Status:
COMPLETED
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
Lead Sponsor:
University of Patras
Conditions:
Platelet Reactivity
Eligibility:
All Genders
18-95 years
Phase:
PHASE4
Brief Summary
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :
- Acute coronary syndrome (unstable angina or myocardial infarction)
- TIMI risk score\>2
- Platelet reactivity in PRU ≥235 24 hours post-PCI
- Age≥75 years and/or weight\<60 Kg
- 4\. Informed consent obtained in writing
Exclusion
- A history of bleeding diathesis
- Chronic oral anticoagulation treatment
- Contraindications to antiplatelet therapy
- Known platelet function disorders
- PCI or coronary artery bypass surgery \< 3 months
- Unsuccessful PCI (residual stenosis \> 30% or flow \< Thrombolysis in myocardial infarction flow 3)
- Planned staged PCI in the next 30 days
- Hemodynamic instability
- hemodialysis
- Creatinine clearance \<25 ml/min
- inability to give informed consent
- High likelihood of being unavailable for the Day 30
- 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 longterm antiplatelet therapy.
- Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thrombocytopenia (\<100.000 / μL) at randomization
- Anaemia (Hct \<30%) at randomization
- Polycythaemia (Hct \> 52%) at randomization
- Periprocedural IIb/IIIa inhibitor administration
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01463150
Start Date
October 1 2011
End Date
July 1 2012
Last Update
July 11 2012
Active Locations (1)
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1
Cardiology Department Patras University Hospital
Rio, Achaia, Greece, 26500