Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI

Study Overview
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Brief Summary
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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)

Official Title
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Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes

Intervention / Treatment
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* Drug: clopidogrel
* Drug: Prasugrel 10 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clopidogrel<br>clopidogrel 150 mg once daily for 30 days (and then 75 mg for additional 11 months - not study related) | Drug: clopidogrel<br>* clopidogrel 150 mg once daily for 30 days<br>* Other names: Plavix;|
| Active Comparator: Prasugrel<br>Prasugrel 10 mg once daily for 30 days (and then clopidogrel 75 mg once daily for additional 11 months - not study related) | Drug: Prasugrel 10 mg<br>* Prasugrel 10 mg once daily for 30 days<br>* Other names: Efient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heparin ADP by Multiplate | Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel, prasugrel, low responder, multiplate, verify now