Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing

Study Overview
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Brief Summary
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Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.

Official Title
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Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Prasugrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: successful PCI 600 mg clopidogrel pretreatment clopidogrel low response assessed with electrode aggregometry (>= 486 AU*min) written informed consent Exclusion Criteria: Contraindications or allergies against study drugs Anemia Any surgery < 6 weeks Increased bleeding risk Oral anticoagulation platelet count < 100.000/µl Prior history of stroke or pathologic intracranial findings GPIIb/IIIa antagonists < 10 days or periprocedural Age > 80 years, < 18 years Body weight < 60 kg Cardiogenic shock Increased risk of bradycardia Moderate liver disease Kidney dialysis Intake of CYP 3A4 inhibitors Pregnancy or lactation Missing pregnancy test for women capable of bearing children

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Ticagrelor<br>A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily | Drug: Ticagrelor<br>* A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily<br>|
| Active Comparator: Prasugrel<br>A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years | Drug: Prasugrel<br>* A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel |  | Day 2 post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of low responders in ticagrelor or prasugrel group | Low platelet response is defined as platelet aggregation values >=468 AU*min | Day 2 post randomization | 
| Proportion of enhanced responders in ticagrelor or prasugrel group | Enhanced platelet response is defined as platelet aggregation values <= 188 AU*min | Day 2 post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel low response, ticagrelor, prasugrel, platelet aggregation