Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes
Conditions
Keywords
clopidogrel, prasugrel, low responder, multiplate, verify now
Brief summary
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)
Interventions
clopidogrel 150 mg once daily for 30 days
Prasugrel 10 mg once daily for 30 days
Sponsors
Study design
Eligibility
Inclusion criteria
* PCI with stenting and Multiplate hep-ADP \> 70 U despite clopidogrel loading
Exclusion criteria
* need for vit K antagonist * women with childbearing potential * breastfeeding women * Planned surgery within 6 months * Intolerance to clopidogrel, prasugrel or aspirin * previous stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heparin ADP by Multiplate | 30 days | Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy |
Countries
Denmark