Coronary Artery Disease Clinical Trial
Official title:
Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention
All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for
clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.
A cut off value has previously been established. Only low-responders with Multiplate values
above the cut off value are included in the study. The patients are randomized to either
clopidogrel 150 mg once daily or Prasugrel 10 mg (age > 75 og bodyweight < 60 kg 5 mg)once
daily for 30 days after the procedure.
Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.
Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified
antiplatelet therapy.
Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major
adverse cardiac events (MACE) at 30 days will be collected and reported but the study size
does not allow for formal statistical analysis The study ends by the 30 days follow up visit
and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study
related)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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