Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating on-treatment platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).

Detailed Description
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Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)on-treatment platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.

Official Title
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Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

Conditions
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Platelet Inhibition, Coronary Stent Implantation

Intervention / Treatment
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* Drug: prasugrel or ticagrelor
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all consecutive PCI patients with stent implantation of our institution Exclusion Criteria: pregnancy

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard therapy<br>standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS) | Drug: Clopidogrel<br>* clopidogrel 75mg od for 12 month<br>* Other names: Plavix;|
| Experimental: individualized therapy<br>dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer | Drug: prasugrel or ticagrelor<br>* prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month<br>* Other names: Brilique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definite Stent Thrombosis | The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis | 30 days | 
| Any Bleeding Event | Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL | 30days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probable Stent Thrombosis | Probable stent thrombosis is considered to have occurred in case of any unexplained death within the first 30 days. any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure | 30days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel-nonresponder, stent thrombosis