The IDEAL-PCI Extended 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). IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit

Detailed Description
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Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry. In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.

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

Conditions
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Coronary Arterioscleroses, Platelet Dysfunction Due to Drugs

Intervention / Treatment
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* Drug: DAPT reduction
* Drug: DAPT on-target
* Drug: DAPT intensification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all consecutive PCI patients Exclusion Criteria: pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bleeding prevention group<br>Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor | Drug: DAPT reduction<br>* Reduction of standard dose DAPT due to low platelet reactivity<br>Drug: DAPT on-target<br>* Standard DAPT within the therapeutic window of platelet reactivity<br>|
| Active Comparator: Ischemia prevention group<br>Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor | Drug: DAPT on-target<br>* Standard DAPT within the therapeutic window of platelet reactivity<br>Drug: DAPT intensification<br>* Intensification of standard dose DAPT due to high platelet reactivity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent thrombosis | stent thrombosis by any Academic Research Consortium (ARC) definition | 1 year | 
| bleeding | bleeding type 1-3 and 5 by Bleeding Academic Research Consortium (BARC) definition | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular Events (MACCE) | death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization | 1 year |