Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry

Study Overview
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Brief Summary
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The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor infusion.

Detailed Description
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Cangrelor administration is currently recommended by international guidelines in patients undergoing PCI who are naïve to P2Y12 inhibitors. These recommendations are based on the large Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) program, which encompassed three randomized controlled trials (RCTs) enrolling both chronic and acute coronary syndromes. Consistently, the aforementioned studies showed the benefit of cangrelor in terms of ischemic events (mainly driven by a reduction of myocardial infarction - MI - and stent thrombosis - ST) in the face of an increased rate of minor bleeding. However, those RCTs were primarily focused on populations at considerable ischemic risk and with predictably low bleeding proneness, including young patients without bleeding risk features. In the contemporary practice, however, PCI is increasingly frequent in patients at high risk of bleeding, who are not formally prevented from being administered with cangrelor by international guidelines and possibly necessitate powerful and rapid-onset platelet inhibition while undergoing complex percutaneous revascularization. The present registry was therefore conceived at the scope of collecting data on the use of cangrelor in high bleeding risk (HBR) patients undergoing contemporary PCI. Specifically, it will assess the frequency of HBR patients in a real-world cohort of individuals treated with cangrelor and will compare the clinical outcomes of HBR and non-HBR patients.

Official Title
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Multicenter, Observational, Retrospective Cohort Study of Patients at High Risk of Bleeding Undergoing Percutaneous Coronary Intervention and Treated With Intravenous Cangrelor Infusion (ICARUS)

Conditions
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Bleeding, Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
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* Drug: Cangrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes Exclusion Criteria: 1. Cangrelor administration as a bridge to surgery

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High bleeding risk<br>Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) | Drug: Cangrelor<br>* Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes<br>|
| Non-high bleeding risk<br>Patients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR) | Drug: Cangrelor<br>* Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of NACE | A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MACE | A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis | 48 hours | 
| Rate of cardiovascular death | Cardiovascular death according to the ARC definition | 48 hours | 
| Rate of myocardial infarction (periprocedural) | Myocardial infarction (periprocedural) according to the 4th Universal definition | 48 hours | 
| Rate of ischemic stroke | An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of infarction, involving the brain, spinal cord or retina | 48 hours | 
| Rate of hemorrhagic stroke | An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of hemorrhage, involving the brain, spinal cord or retina | 48 hours | 
| Rate of definite or probable stent thrombosis | Definite or probable stent thrombosis according to the ARC definition | 48 hours | 
| Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding | Bleeding grade 2,3 and 5 according to the ARC definition | 48 hours | 
| Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding | Bleeding grade 3 and 5 according to the ARC definition | 48 hours | 
| Rate of MACE | A composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis | During hospital stay (up to discharge day), on average 5 days | 
| Rate of cardiovascular death | Cardiovascular death according to the ARC definition | During hospital stay (up to discharge day), on average 5 days | 
| Rate of myocardial infarction | Myocardial infarction according to the 4th Universal definition | During hospital stay (up to discharge day), on average 5 days | 
| Rate of ischemic stroke | An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of infarction, involving the brain, spinal cord or retina | During hospital stay (up to discharge day), on average 5 days | 
| Rate of hemorrhagic stroke | An acute episode of focal or global neurological dysfunction caused by central nervous system (CNS) vascular injury as a result of hemorrhage, involving the brain, spinal cord or retina | During hospital stay (up to discharge day), on average 5 days | 
| Rate of definite or probable stent thrombosis | Definite or probable stent thrombosis according to the ARC definition | During hospital stay (up to discharge day), on average 5 days | 
| Rate of blood transfusion | Blood transfusion during hospital stay | During hospital stay (up to discharge day), on average 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Cangrelor, High bleeding risk, Coronary artery disease, Acute myocardial infarction