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not started due to regulatory reasons
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bleeding prevention group | Active Comparator | Patients with reduction of standard dose DAPT due to low platelet reactivity to asprin and/or P2Y12 inhibitor |
|
| Ischemia prevention group | Active Comparator | Patients with intensification of standard dose DAPT due to high platelet reactivity to asprin and/or P2Y12 inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPT reduction | Drug | Reduction of standard dose DAPT due to low platelet reactivity |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular Events (MACCE) | death, cardiovascular death, myocardial infarction, stroke, ischemia driven revascularization | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guenter Christ, MD | Kaiser Franz Josef Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Franz Josef Hospital | Vienna | 1100 | Austria |
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| Label | URL |
|---|---|
| IDEAL-PCI Registry | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| DAPT on-target | Drug | Standard DAPT within the therapeutic window of platelet reactivity |
|
| DAPT intensification | Drug | Intensification of standard dose DAPT due to high platelet reactivity |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |